[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"4th Military Clinical Hospital with Polyclinic, Poland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":241},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,81,112,148,183,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100643078","role-of-intraoperative-computed-tomography-in-assessment-of-spine-instability-in-lumbar-degenerative-disease-100643078",false,"NCT07644507","Role of Intraoperative Computed Tomography in Assessment of Spine Instability in Lumbar Degenerative Disease","Analysis of Intraoperative Computed Tomography Images in the Assessment of Radiological Features of Lumbar Spine Instability in Patients Undergoing Surgery for Degenerative Disease: Validation of Diagnostic Parameters","INSIGHT-CT","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Degenerative lumbar spine pathology requiring surgical treatment (e.g., degenerative spondylolisthesis, lumbar spinal stenosis, isthmic spondylolisthesis)\n* Planned or performed lumbar decompression with instrumented fusion\n* Available intraoperative computed tomography (CT) with comparative preoperative imaging (retrospective cohort), or intraoperative CT performed during the index surgery (prospective cohort)\n* No prior surgery at the spinal level under evaluation; previous surgery at other levels permitted\n* Stable general medical condition allowing planned clinical evaluation\n* Written informed consent prior to participation (prospective cohort only)\n\nExclusion Criteria:\n\n* Non-degenerative spinal pathology, including acute traumatic spinal injury, primary or metastatic spinal tumor, spinal infection (e.g., osteomyelitis, discitis), or inflammatory spinal disease (e.g., ankylosing spondylitis)\n* Inadequate or incomplete imaging data, including poor-quality intraoperative CT or absence of comparative preoperative imaging\n* Emergency or non-elective surgery\n* Revision surgery involving the same spinal level(s)\n* Inability to provide informed consent (prospective cohort only)\n* Neuromuscular or congenital spinal deformity significantly altering spinal biomechanics (e.g., scoliosis \\>20°, congenital segmentation anomalies)","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","This study examines how well computed tomography (CT) imaging performed during spine surgery - known as intraoperative CT - can detect instability in the lower (lumbar) part of the spine. Spinal instability means that the bones of the spine move more than they normally should, which can contribute to pain and may affect the outcome of surgery.\n\nBefore surgery, doctors usually check for this instability using X-rays taken while the patient bends forward and backward. These X-rays do not always show instability clearly. During surgery, the patient lies face down and the muscles are fully relaxed, which can change how the spine appears on imaging.\n\nThe purpose of this study is to learn whether CT images taken during surgery can identify signs of lumbar spinal instability as reliably as standard imaging performed before surgery, and whether they can reveal signs of instability that were not visible beforehand. To do this, the researchers will review imaging and clinical information from adults who are undergoing surgery for degenerative (wear-related) conditions of the lower spine.\n\nThis study does not change a patient's surgery or treatment. It only analyzes imaging and clinical information that are already part of standard care. The findings may help guide imaging and surgical decisions in lumbar spine surgery in the future.",[25,26,27,28],"Degenerative Lumbar Spine Diseases","Lumbar Spinal Instability","Degenerative Spondylolisthesis","Lumbar Spinal Stenosis","NOT_YET_RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":21},"2026-08-01",{"date":37,"type":21},"2027-12-01",{"name":39,"class":40},"4th Military Clinical Hospital with Polyclinic, Poland","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":41},"100588792","normobaric-oxygen-therapy-in-colorectal-cancer-patients-100588792","NCT06946004","Normobaric Oxygen Therapy in Colorectal Cancer Patients","The Potential of Normobaric Oxygen Therapy to Enhance Erythropoiesis, Reduce Oxidative Stress, and Modulate Immune Function in Colorectal Cancer Patients Undergoing Chemotherapy: Study Protocol for a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial (NBO-ONCO)","NBO-ONCO","Inclusion Criteria:\n\n* age between 18 and 80 years (participants must be adults)\n* diagnosed with CRC (stage II-IV, scheduled for standard chemotherapy (for study and control groups)\n* baseline hemoglobin levels above 10 g\u002FdL\n* no concurrent hematologic malignancies\n* eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (ensuring participants are ambulatory and capable of self-care)\n* life expectancy of at least 12 months (participants are expected to survive the duration of the study)\n* ability and willingness to comply with all study procedures and schedules (including NBO therapy sessions and follow-up visits)\n* adequate organ function as determined by laboratory tests (liver function tests - ALT, AST), renal function tests (serum creatinine, eGFR)\n* women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use effective contraception during the study (to ensure safety for potential pregnancies)\n* written informed consent obtained prior to any study-related procedures (participants must understand and agree to all aspects of the study).\n\nExclusion Criteria:\n\n* age under 18 years or over 80 years\n* severe cardiovascular or respiratory conditions (e.g., unstable angina, recent myocardial infarction, advanced COPD)\n* severe anemia (hemoglobin \\\u003C10 g\u002FdL) or any hemolytic disorder that could confound study outcomes\n* uncontrolled diabetes mellitus (e.g., HbA1c \\>8.0% or poor glycemic control requiring frequent hospitalizations)\n* pregnancy or breastfeeding\n* severe infection or immunocompromised status unrelated to cancer (e.g., advanced HIV infection)\n* current psychiatric or neurological disorders that could interfere with study participation\n* participation in other investigational therapies within the last 30 days; (9) lack of written informed consent for study participation\n* autoimmune or inflammatory conditions (e.g., lupus, rheumatoid arthritis on immunosuppressive therapy) that significantly alter immune responses\n* presence of any contraindication for NBO therapy (e.g., active bleeding, acute infections, inflammation of the optic nerve, epilepsy or seizures, uncontrolled diabetes as noted above, pneumothorax, emphysema, electronic implants).","80 Years",{"count":52,"type":21},254,"INTERVENTIONAL",[55],"NA","Colorectal cancer (CRC) patients undergoing chemotherapy often experience anemia, oxidative stress, and immune suppression, significantly impacting their quality of life and treatment outcomes. Normobaric oxygen (NBO) therapy, which delivers oxygen at atmospheric pressure with elevated oxygen concentration, has shown a potential to enhance erythropoiesis, reduce oxidative stress, and modulate immune function. However, its efficacy in CRC patients remains underexplored. This study aims to evaluate the effects of NBO exposures on (1) supporting erythropoiesis by measuring erythropoietin (EPO) levels and hypoxia-inducible factors (HIF-1α), (2) reducing oxidative stress and improving stress and emotional well-being, and (3) modulating immune function by assessing cytokine profiles. Secondary objectives include assessing the impact of NBO on patient-reported outcome measures (PROMs) such as stress, anxiety, depression, and quality of life. This is a prospective, randomized, double-blind, placebo-controlled clinical trial. A total of 254 CRC patients undergoing chemotherapy will be randomized 1:1 to receive either active NBO therapy (n=127) or placebo NBO therapy (n=127). The intervention consists of 10 NBO sessions over five weeks. Primary outcomes include biomarkers of erythropoiesis, oxidative stress, and immune response. Secondary outcomes assess quality of life and psychological well-being. Data will be collected at baseline, mid-intervention, post-intervention, and during two follow-up visits (3- and 6-months post-intervention). The study hypothesizes that NBO therapy will improve erythropoiesis, reduce oxidative stress, and enhance immune function in CRC patients, leading to improved quality of life and clinical outcomes. Findings from this trial may establish NBO as a novel supportive therapy for CRC patients undergoing chemotherapy.",[58],"Colorectal Cancer (CRC)",[60,61,62,63,64,65,66,67,68,69,70,71,72],"colorectal cancer","normobaric oxygen therapy","chemotherapy-induced anemia","oxidative stress","immune modulation","erythropoiesis","supportive cancer care","adverse effects","stress","anxiety","depression","psychological well-being","quality of life","2025-04-23",{"date":75,"type":33},"2025-04-27",{"date":77,"type":21},"2025-11-01",{"date":79,"type":21},"2028-11-01",{"name":39,"class":40},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":89,"targetDuration":4,"studyType":53,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100539516","phase-3-cardioprotection-with-dapagliflozin-in-breast-cancer-patients-treated-with-anthracycline---protectaa-trial-100539516","NCT06304857","CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL","A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy","PROTECTAA","Inclusion Criteria:\n\n* Age \\> 18 years and \\\u003C 80 years.\n* Diagnosis of invasive breast cancer \\[stage I-III\\] and planned anthracycline treatment within 60 days.\n* Signed Informed Consent to participate in the study.\n\nExclusion Criteria:\n\n* Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.\n* Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.\n* Left ventricular ejection fraction \\\u003C 50% at the time of the screening.\n* Severe valvular heart disease.\n* A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).\n* A history of stroke.\n* Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.\n* Pulmonary hypertension.\n* Uncontrolled arterial pressure or systolic pressure \\\u003C 80 mmHg at screening (at the discretion of the investigator).\n* BMI \\> 40 kg\u002Fm2.\n* Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg\u002Fdl or HbA1C ≥ 6,5% (48 mmol\u002Fmol).\n* Pregnancy or breastfeeding.\n* Lack of compliance to use highly effective method of birth control.\n* Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.\n* Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.\n* Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.\n* eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2 according to CKD EPI.\n* Life expectancy \\\u003C 12 months or cancer disease stage IV according to the TNM classification.\n* Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.\n* Anemia with Hemoglobin \\\u003C 9 g\u002Fdl.\n* Kidney failure \\> G2 (according to KDIGO classification).\n* Liver disorders, Child-Pugh score \\> 4.\n* Known, active infections with HIV, HBV, HCV, tuberculosis.\n* Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.",{"count":90,"type":21},188,[92],"PHASE3","The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.",[95,96],"Breast Cancer","Heart Failure",[98,99,100,101],"breast cancer","heart failure","ejection fraction","anthracyclines","RECRUITING","2024-12-02",{"date":105,"type":33},"2024-12-04",{"date":107,"type":33},"2024-04-15",{"date":109,"type":21},"2027-12-31",{"name":39,"class":40},3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":53,"phases":122,"briefSummary":123,"conditions":124,"keywords":132,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":41},"100570460","the-potential-protective-effect-of-using-muscle-relaxants-during-electroporation-ablation-pfa-100570460","NCT06707532","The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)","The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart","Inclusion Criteria:\n\n* Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation\n\nExclusion Criteria:\n\n* Patients with allergies to the general anaesthetics used, genetic diseases of the neuromuscular plateau - e.g. Duchenne dystrophy, myasthenia gravis - and patients who do not gived informed consent to participate in the study will be excluded from the study.","90 Years",{"count":121,"type":21},32,[55],"The study aims to improve the safety of the electroporation ablation (PFA) procedure by using muscle relaxants to reduce skeletal muscle damage during the procedure. It will also assess myocardial damage to improve the procedure's quality and speed up recovery after the procedure.",[125,126,127,128,129,130,131],"Kidney Failure, Acute","Myopathy; Drugs","Heart Arrhythmia","Succinylcholine Sensitivity","Muscle Relaxation","General Anesthetic Drug Adverse Reaction","Projection",[133,134,135,136,137,138,139],"electroporation ablation (PFA)","muscle relaxants","rocuronium","chronic pain","acute kidney failure","chronic heart failure","drug protection","2024-11-26",{"date":142,"type":33},"2024-11-27",{"date":144,"type":33},"2024-08-01",{"date":146,"type":21},"2025-12-01",{"name":39,"class":40},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":155,"targetDuration":4,"studyType":53,"phases":156,"briefSummary":157,"conditions":158,"keywords":166,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":41},"100556058","evaluation-of-the-effectiveness-of-two-methods-of-regional-anesthesia-during-s-icd-implantation-procedure-100556058","NCT06520150","Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.","Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During Subcutaneous Implantable Cardioverter-defibrillator (SICD) Implantation Procedure.","Inclusion Criteria:\n\n* patients aged 18-90 years requiring S-ICD implantation for cardiac indications,\n* high risk of anesthesia (ASA II or higher), patients giving informed consent to participate in the study.\n\nExclusion Criteria:\n\n* absolute contraindications to regional anesthesia such as generalized coagulation disorders, inflammation at the site of anesthesia, allergy to the drugs used for regional anesthesia\n* lack of consent of the patient for the conducted procedure,\n* inability to cooperate with the patient - such as severe mental retardation, unregulated mental illness with motor agitation, advanced neurodegenerative diseases such as Parkinson's disease\u002FAlzheimer's,\n* inability to give informed consent to participate in the study.",{"count":121,"type":21},[55],"Our study consists of a combination of regional blockade ('local' anesthesia) of the anterior and lateral chest wall in the form of a thin needle prick and the supply of local anesthetic drugs to the area of the relevant chest wall structures to exclude all stimuli, including pain from the operative site. A short-acting analgesic and sedative drug will be administered intravenously throughout the procedure - in a dose that allows the required contact between the patient and the anesthetist. If necessary, the dose of the drug may be increased to maintain pain comfort throughout the procedure.\n\nThe anesthetic team will be with the patient throughout the procedure to ensure comfort and safety.",[159,160,161,162,163,164,165],"Chest Pain","Pain, Procedural","Pain, Postoperative","Analgesia","Regional Anesthesia Morbidity","Anesthesia, Local","ICD",[167,168,169,170,171,172,173,174,175],"Superficial Serratus Anterior Plane Block (SSAP)","Superficial Parasternal Intercostal Plane Block (SPIP)","Pectoserratus Plane Blocks (PSP)","Regional anaesthesia","Subcutaneous implantable defibrillator (S-ICD)","thorax blockade","less invasive","implantation","pain treatment","2024-07-23",{"date":178,"type":33},"2024-07-25",{"date":180,"type":33},"2024-06-16",{"date":146,"type":21},{"name":39,"class":40},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":53,"phases":193,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":41},"100525594","innovative-application-of-pressure-gradient-measurement-in-internal-carotid-stenosis-in-patients-undergoing-cas-100525594","NCT06123767","Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS","Evaluation of Diagnostic and Predictive Capabilities of Novel Application of Carotid Carotid Stenosis Pressure Gradient Measurement in Patients Undergoing Percutaneous Carotid Angioplasty and Stenting (CAS).","NOTICE-CAS","Inclusion Criteria:\n\n* Stenosis of the internal carotid artery in symptomatic patients: \\> 50%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation\n* Stenosis of the internal carotid artery in asymptomatic patients: \\>60%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation\n* Age of patients: \\> 18 years of age\n* Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Inability to obtain informed consent to participate in the study.\n* Difficult anatomy of the aortic arch and the descending cephalic arteries (increased atherosclerotic lesions, acute angle of departure of the common carotid arteries, kinking of the internal carotid arteries).",{"count":192,"type":21},200,[55],"About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis.\n\nIn 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis.\n\nCarotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems.\n\nOBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit.\n\nPRIMARY ENDPOINTS:\n\n1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS\n2. Assessment of cognitive symptoms using before and after CAS\n3. Assessment of neurological symptoms before and after CAS\n4. Assessment of otolaryngological symptoms before and after CAS\n\nSECONDARY ENDPOINTS:\n\nCreation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis.\n\nA final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.",[196,197,198],"Carotid Artery Stenosis","Carotid Artery Stenting","Stroke",[200,201,202,196,203,204],"CAS (carotid artery stenting)","FFR (fractional flow reserve)","FFR-CT (Fractional Flow Reserve - Computed Tomography)","Functional assessment of the stenosis","Decision making algorithm","2024-03-05",{"date":207,"type":33},"2024-03-07",{"date":209,"type":21},"2024-04-01",{"date":211,"type":21},"2027-07-31",{"name":39,"class":40},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":53,"phases":224,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100508145","comparison-of-the-efficacy-and-safety-of-cardioneuroablation-to-permanent-pacing-in-patients-with-an-implanted-pacemaker-for-symptomatic-bradycardia-100508145","NCT05896592","Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.","A Multicenter, Randomized, Double-blind, Research Study comparinG the Efficacy and Safety of cardioneuroablaTion vs Permanent Pacing in Patients With an implantabLE PACEmaker for Symptomatic Bradycardia.","GENTLE-PACE","Inclusion Criteria:\n\n* Patients who underwent pacemaker implantation before 50 years old due to sinus node and\u002For atrioventricular node dysfunction\n* Positive response to atropine test\n* Age between 18-65 years\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Own heart rate \\\u003C30\u002Fmin\n* Fainting after pacemaker therapy initiation\n* Persistent and sustained atrial fibrillation\n* History of myocarditis\n* History of myocardial infarction\n* History of cardiac surgery\n* History of ablation procedures\n* Congenital heart defects\n* Congenital atrioventricular block\n* Neuromuscular and neurodegenerative diseases\n* Indications for expanding the pacemaker system to ICD\u002FCRT-D\n* Pregnancy\n* Renal insufficiency with GFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Age below 18 and above 65 years\n* HAS-BLED score \\>\u002F= 3 points","65 Years",{"count":223,"type":21},99,[55],"Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM). Although PM remains the main therapeutic approach for most patients with SND\u002FAVB, long-term PM therapy can be associated with various limitations, complications, and the need for device and electrode replacement. There is increasing evidence for the effectiveness of an alternative approach to functional bradycardia associated with excessive vagal activation - cardioneuroablation (CNA). The method leads to the alleviation or complete resolution of bradycardia symptoms, as well as reflex syncope, providing an opportunity to discontinue PM therapy.\n\nPrimary aims\n\n1.Evaluation of the efficacy and safety of CNA as a therapy allowing for discontinuation of PM therapy in patients with SND or AVB.\n\nSecondary aims\n\n1. Evaluation of the efficacy and safety of CNA as a therapy allowing for the optimization of PM therapy in patients with SND and AVB.\n2. Development of a diagnostic algorithm allowing for the identification of patients with SND and\u002For AVB suitable for CNA and discontinuation of PM and TLE therapy.\n3. In addition, blood samples will be collected for future analysis and biobanking.\n\nMethodology\n\nInclusion criteria\n\n1. Patients up to 50 years old who underwent pacemaker implantation due to sinus node and\u002For atrioventricular node dysfunction\n2. Positive response to atropine test\n3. Age between 18-65 years\n4. Signed informed consent to participate in the study\n\nExclusion criteria\n\n1. Own heart rate \\\u003C30\u002Fmin\n2. Fainting after pacemaker therapy initiation\n3. Persistent and sustained atrial fibrillation\n4. History of myocarditis\n5. History of myocardial infarction\n6. History of cardiac surgery\n7. History of ablation procedures\n8. Congenital heart defects\n9. Congenital atrioventricular block\n10. Neuromuscular and neurodegenerative diseases\n11. Indications for expanding the pacemaker system to ICD\u002FCRT-D\n12. Pregnancy\n13. Renal insufficiency with GFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n14. Age below 18 and above 65 years\n15. HAS-BLED score \\>\u002F= 3 points\n\nRandomization, study scheme Qualified patients will be randomly assigned (1:1:1) to group 1 undergoing first-stage invasive electrophysiology study (EPS), extracardiac vagus nerve stimulation (ECVS) and CNA with continued PM therapy and implantable loop recorder (ILR) implantation, to group 2 undergoing first-stage EPS and ECVS with continued PM therapy, ILR implantation, and no CNA, and to group 3 where patients will undergo observation only for the entire study. The follow-up time will be 18 months. Groups 1 and 2 will be blinded. Two months after the first invasive procedure, the secondary endpoint-stimulation rate in all groups will be assessed. In addition, a non-invasive evaluation of the efficacy of CNA and the incidence of syncope (MAS) and collapse (paraMAS) will take place in group 1, as well as an evaluation of the pacing percentage. After another month during the second hospitalization, the following will be performed: EPS and ECVS, and repeat CNA if ECVS does not show full parasympathetic cardiac denervation. In group 2, after 2 months, non-invasive tests will also be performed to assess and presence of MAS, paraMAS symptoms, and to assess pacing rates. After another month, during the second hospitalization, the following will be performed: EPS, ECVS and CNA. Group 1 and 2 patients will have their pacemaker set to VVI\u002FAAI 30\u002Fmin. Group 3 patients will then be evaluated for pacing rates and MAS, paraMAS symptoms. At the third visit, one month after the second invasive procedure in group 1 and 2 patients, the pacing percentage will be assessed. Patients with zero pacing percentage PM will be put on ODO\u002FOVO\u002FOAO-pacing off mode. Patients with a pacing percentage greater than zero PM will be set to their optimal mode. A pacing percentage of \\\u003C0.1% will be treated as 0%, which will be confirmed in the ILR control. For the next 12 months, patients will be observed. During this period, at the next 4 visits repeated every 3 months, groups 1 and 2 will undergo a non-invasive assessment of CNA efficacy and bradycardia symptoms, while group 3 will be evaluated for MAS, paraMAS and pacing percentage assessment. At the 7th visit, the qualification of patients in groups 1 and 2 for discontinuation of continued pacing treatment will take place, with possible qualification for TLE.\n\nJustification Early and late results of a new strategy which is CNA, indicate the possibility of developing an new approach that allows patients with functional bradycardia to decide whether to discontinue or optimize PM therapy. However, standardized approaches based on noninvasive and invasive techniques have not yet been validated and evaluated in a prospective, multicenter, randomized, controlled trial with long-term remote follow-up, including ILR.",[227,228],"Bradycardia","Syncope",[230,231,232],"cardioneuroablarion","functional bradycardia","pacemaker treatment discontinuation","2023-12-30",{"date":235,"type":33},"2024-01-03",{"date":144,"type":21},{"date":238,"type":21},"2029-07-31",{"name":39,"class":40},2,""]