[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608041":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":60,"locations":68,"responsibleParty":86,"collaborators":10,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":10,"enrollmentInfo":98,"targetDuration":101,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":117,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"SABAMED Medical Center Ltd.","NETWORK",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"vagally mediated bradycardia",null,"This cohort includes patients with vagally mediated bradycardia, including cardioinhibitory vasovagal syncope, carotid sinus syndrome, or functional sinus node dysfunction related to excessive parasympathetic activation. Patients are referred for interventional treatment due to recurrent syncope or symptomatic bradycardia refractory to conservative management. Interventions include cardioneuroablation or autonomic modulation procedures aimed at reducing vagal influence on the sinus and atrioventricular nodes while preserving physiological autonomic balance. Diagnosis is confirmed based on tilt-table testing, ECG documentation, and symptom correlation.",[13,14],"Procedure: cardioneuroablation","Behavioral: Hybrid Cardiac Rehabilitation Program",{"label":16,"type":10,"description":17,"interventionNames":18},"IST\u002FPOTS","This cohort includes patients diagnosed with inappropriate sinus tachycardia (IST) or postural orthostatic tachycardia syndrome (POTS) who are undergoing interventional treatment due to insufficient response to pharmacological or behavioral therapy. Interventions include sinus node-sparing thoracoscopic ablation aimed at improving symptoms and quality of life. Autonomic dysfunction is confirmed based on standardized testing, and the interventions target neural pathways involved in excessive sympathetic or inadequate parasympathetic control of heart rate and vascular tone.",[19,14,20],"Procedure: SN sparing hybrid ablation","Device: Transcutaneous Vagus Nerve Stimulation (tVNS)",{"label":22,"type":10,"description":23,"interventionNames":24},"Cardiac sympathetic denervation","Patients with clinical indications for stand-alone or concomittant, hybrid cardiac sympathetic denervation. This cohort includes patients with arrhythmias driven by excessive sympathetic activation, such as congenital long QT syndrome (LQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), and refractory ventricular tachyarrhythmias. Patients are referred for cardiac sympathetic denervation (CSD) due to high arrhythmic burden despite optimal pharmacologic treatment or recurrent implantable cardioverter-defibrillator (ICD) shocks. CSD is performed via thoracoscopic access and involves ablation or removal of the stellate ganglion and thoracic sympathetic chain (typically T2-T4). The goal is to reduce sympathetic drive, stabilize cardiac electrophysiology, and prevent life-threatening arrhythmias.",[25,14],"Procedure: Cardiac sympathetic denervation",{"label":27,"type":10,"description":28,"interventionNames":29},"other rare subgroups and neuromodulation intervention","This cohort includes patients with rare autonomic or electrophysiological syndromes undergoing neuromodulatory interventions as part of individualized treatment strategies. Interventions may include transcutaneous vagus nerve stimulation (tVNS), structured cardiac rehabilitation programs with autonomic modulation components, and other non-invasive or minimally invasive techniques aimed at improving autonomic balance and symptom burden. This group is characterized by heterogeneous diagnoses, including overlapping or atypical forms of autonomic dysfunction, and is managed with a personalized, multidisciplinary approach integrating physiologic monitoring, rehabilitation, and neuromodulation.",[13,19,25,14,20],[31,36,40,43,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"PROCEDURE","cardioneuroablation","Cardioneuroablation and related autonomic interventions aim to modulate parasympathetic and\u002For sympathetic inputs to the heart in order to treat functional bradycardia, inappropriate sinus tachycardia, vasovagal syncope, and other reflex arrhythmias. Techniques include catheter-based ablation of ganglionated plexi, thoracoscopic sinus node-sparing ablation, cardiac sympathetic denervation, and percutaneous stellate ganglion blockade. These procedures are tailored to each patient's autonomic profile and diagnosis.",[27,9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"SN sparing hybrid ablation","Sinus node-sparing hybrid ablation is a minimally invasive surgical procedure that modulates autonomic inputs to the sinoatrial node while preserving its intrinsic function. The intervention is performed via video-assisted thoracoscopic surgery (VATS) and targets the epicardial autonomic ganglia and neural connections responsible for inappropriate sinus tachycardia or autonomic dysfunction. Unlike traditional sinus node modification, this approach avoids direct ablation of the sinus node and focuses on surrounding autonomic structures. The goal is to reduce pathologic chronotropic activity and improve symptom control without inducing iatrogenic bradycardia.",[16,27],{"type":32,"name":22,"description":41,"armGroupLabels":42,"otherNames":10},"Cardiac sympathetic denervation is an interventional procedure aimed at reducing excessive sympathetic drive to the heart by ablating or removing components of the sympathetic nervous system. It is typically performed via a thoracoscopic approach and involves bilateral or left-sided denervation of the stellate ganglion and thoracic sympathetic chain (usually T2-T4). CSD is used in patients with arrhythmias associated with sympathetic overactivity, such as long QT syndrome, catecholaminergic polymorphic ventricular tachycardia (CPVT), or autonomic dysfunction-related tachyarrhythmias. The procedure helps reduce arrhythmic burden, modulate autonomic tone, and improve symptom control.",[22,27],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":10},"BEHAVIORAL","Hybrid Cardiac Rehabilitation Program","A two-phase program combining supervised inpatient exercise, respiratory training, psychological support, and education with a home-based telerehabilitation phase (Nordic walking, remote ECG and vital sign monitoring). The aim is to restore functional capacity, reduce symptoms, and improve autonomic balance.",[22,16,27,9],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"DEVICE","Transcutaneous Vagus Nerve Stimulation (tVNS)","Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique in which the vagus nerve is stimulated via surface electrodes placed on the skin, most commonly in the auricular region (e.g., tragus or cymba conchae). The intervention is performed using a certified external stimulation device that delivers mild electrical impulses to activate afferent vagal fibers. tVNS is used in the treatment of various conditions, including depression, epilepsy, migraine, chronic pain, and disorders of the autonomic nervous system such as postural orthostatic tachycardia syndrome (POTS) and inappropriate sinus tachycardia (IST). In this study, tVNS is applied as a supportive neuromodulatory therapy with individualized stimulation parameters and session duration based on clinical response and patient tolerance.",[16,27],[54,57],{"name":55,"affiliation":5,"role":56},"Sebastian Stec, Prof., MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":58,"affiliation":5,"role":59},"Marta Kornaszewska, MD","STUDY_DIRECTOR",[61,65],{"name":55,"role":62,"phone":63,"phoneExt":10,"email":64},"CONTACT","+48600298022","smstec@wp.pl",{"name":58,"role":62,"phone":66,"phoneExt":10,"email":67},"+48881340342","mkornaszewska@gmail.com",[69],{"facility":70,"status":71,"city":72,"state":10,"zip":10,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"SabaMed","RECRUITING","Rzeszów","Poland","PL",{"type":76,"coordinates":77},"Point",[78,79],21.99901,50.04132,{"lat":79,"lon":78},[82],{"name":83,"role":62,"phone":84,"phoneExt":10,"email":85},"Daker Al Soori, MD","+4817 85 06 280","daker.alsoori@sabamed.pl",{"type":87,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100608041","polish-registry-of-cardioneuroablation-and-cardioneuromodulation-100608041",false,"NCT07196397","POLish Registry of CArdioneuroablation and CArdioneuromodulation","POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes","POL-CA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of at least one of the following conditions:\n\n  * Inappropriate sinus tachycardia (IST)\n  * Postural orthostatic tachycardia syndrome (POTS)\n  * Vasovagal syncope (VVS)\n  * Cardioinhibitory carotid sinus syndrome (CSS)\n  * Symptomatic sinus bradycardia or functional AV block\n  * Orthostatic hypotension (OH)\n* History of recurrent autonomic symptoms (e.g., syncope, bradycardia, palpitations, orthostatic intolerance)\n* Undergoing or previously underwent interventional treatment affecting cardiac autonomic innervation (e.g., cardioneuroablation, SN-sparing ablation, cardiac sympathetic denervation)\n* Provided written informed consent (for prospective arm)\n\nExclusion Criteria:\n\n* Structural heart disease requiring surgical intervention\n* Permanent pacemaker or ICD implanted prior to enrollment\n* Inability to complete follow-up assessments or questionnaires\n* Severe psychiatric comorbidities impairing participation\n* Participation in another interventional clinical trial","ALL","18 Years",{"count":99,"type":100},1000,"ESTIMATED","3 Years","OBSERVATIONAL","The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. This is an observational, controlled study with retrospective, clinical data analysis of previously treated patients and the analysis of syncopal patients prospectively recruited into the study. The aim of the POL-CA registry is to create a platform for physicians to record treatment data for patients undergoing procedures that affect innervation or modify cardiovascular reflexes (cardioneuroablation, cardioneuromodulation) in order to provide a multicentre summary of population characteristics and treatment outcomes based on a standardized POL-CA questionnaire and methodology for various arrhythmias.",[105,106,107,108,109,110,111,112,113,114,115,116],"Vasovagal Syndrome VVS","Cardioinhibitory Carotid Sinus Syndrome CSS","Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV","Postural Orthostatic Tachycardia Syndrome POTS","Orthostatic Hypotension","Inappropriate Sinus Tachycardia Syndrome IST","Vasospastic Angina","Microvascular Angina","Ventricular Arrythmia","Raynaud Phenomena","Autonomic Dysfunction","Autonomic Diseases",[33,118,119,120,121,122,123,124,125,126],"cardiac sympathetic denervation","sinoatrial node sparing hybrid ablation","catheter ablation","neural stimulation","cardioneuromodulation","percutaneus stellate ganglion blockage","cardiac rehabilitation","cardiovascular autonomic tests","syncope","2025-09-21",{"date":129,"type":130},"2025-09-29","ACTUAL",{"date":132,"type":130},"2024-11-21",{"date":134,"type":100},"2031-12-31",{"name":5,"class":6},1]