[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medtronic Cardiac Rhythm and Heart Failure\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":169},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,70,90,112,125,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100053262","advancing-clinical-heart-failure-outcomes-leveraging-defibrillation-lead-implant-system-for-left-bundle-branch-area-pacing-100053262",false,"NCT07526896","Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing","ACHIEVED LBBAP","Inclusion Criteria:\n\n* Subject meets current ACC\u002FAHA\u002FHRS guidelines for implantation of a CRT-D device.\n* Subject has documented LVEF ≤ 35% within 60 days of enrollment.\n* Subject meets the criteria for presence of Strauss-defined LBBB.\n* Subject meets NYHA classification II or III.\n* Subject is willing and able to provide written consent.\n* Subject is at least 18 years of age at the time of consent.\n* Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.\n* The subject's medical records must be accessible by the enrolling site over the follow-up period.\n\nExclusion Criteria:\n\n* Subject has documented myocardial infarction before enrollment.\n* Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.\n* Subject has 2nd or 3rd degree AV block.\n* Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).\n* Subject has intrinsic (non-paced) QRS duration ≤ 120ms.\n* Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.\n* Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).\n* Subject underwent valve surgery within 90 days prior to enrollment.\n* Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.\n* Subject is post-heart transplantation or is actively listed on the transplantation list.\n* Subject is implanted with a left ventricular assist device (LVAD).\n* Subject has severe renal disease.\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.\n* Subject has complex and uncorrected congenital heart disease.\n* Subject has life expectancy of less than 12 months.\n* Subject is pregnant or breastfeeding.\n* Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"NA","This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis",[26,27],"Heart Failure","Systolic Bundle Branch Block, Left","NOT_YET_RECRUITING","2026-07-09",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":20},"2026-08",{"date":36,"type":20},"2029-09",{"name":38,"class":39},"Medtronic Cardiac Rhythm and Heart Failure","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100568255","elevate-hfpef-clinical-study-100568255","NCT06678841","ELEVATE-HFpEF Clinical Study","Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)","ELEVATE-HFpEF","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. Documented EF ≥50% within the preceding 12 months\n3. HFpEF defined as:\n\n   1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR\n   2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n      * Interstitial \u002F pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure\n      * Elevated NT-proBNP in the last year defined as \\>400 pg\u002Fm for patients with no AF or paroxysmal AF, or \\>900 pg\u002Fml for patients with ≥persistent AF\n      * Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)\n      * Echo criteria defined by ≥2 of:\n\n        * LV wall thickness ≥ 12 mm\n        * LV mass index (BSA indexed LVH): sex at birth male \\>115 g\u002Fm2, sex at birth female \\>95 g\u002Fm2\n        * Relative wall thickness ≥0.42\n        * E\u002Fe' ≥15 in sinus rhythm (or \\> 11 in the setting of atrial fibrillation) OR septal \\\u003C7 cm\u002Fs or lateral e' \\\u003C10cm\u002Fs\n        * Tricuspid regurgitation (TR) velocity \\>2.8 m\u002Fs\n        * Left atrial (LA) enlargement, defined by LA volume index \\>34 ml\u002Fm2\n4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days\n5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)\n6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).\n\nExclusion Criteria:\n\n1. Improved or recovered EF (i.e., prior LVEF\\\u003C50%)\n2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))\n3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)\n4. Average heart rate \\\u003C50 bpm or symptomatic bradycardia\n5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.\n6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and\u002For inotropic drugs.\n7. Severe obesity defined as BMI \\>45.\n8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \\\u003C50 bpm or evidence of ventricular pauses exceeding 6 seconds\n9. Planned AF ablation\n10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)\n11. Hypertrophic cardiomyopathies\n12. Uncontrolled hypertension as defined by BP \\>160\u002F100 mmHg on two measurements ≥15 minutes apart\n13. End Stage Renal Disease (CKD 4 or greater)\n14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)\n15. Significant primary pulmonary disease on home oxygen\n16. Known contraindication for a pacemaker implant\n17. Advanced co-morbidity with life expectancy \\\u003C 1 year\n18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.\n19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).","40 Years",{"count":50,"type":20},700,[23],"ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).",[54],"Heart Failure With Preserved Ejection Fraction (HFpEF)",[26,56,57,58,59],"Heart Disease","Cardiovascular Disease","Concentric Hypertrophy","Concentric Remodeling","RECRUITING","2026-06-25",{"date":63,"type":32},"2026-06-29",{"date":65,"type":32},"2025-07-09",{"date":67,"type":20},"2029-02",{"name":38,"class":39},46,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100640691","impact-of-allometric-pacing-rate-on-ventricular-diastolic-function-and-cerebral-blood-flow-in-hypertensive-patients-with-sinus-node-dysfunction-100640691","NCT07589452","Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction","Inclusion Criteria:\n\n* ≥65 years of age\n* Planned implantation of a dual chamber pacemaker with physiological pacing\n* Resting sinus heart rate ≤60 bpm, or average 24 hour Holter heart rate ≤60 bpm\n* Documented history of hypertension or office systolic blood pressure ≥130 mmHg\n\nExclusion Criteria:\n\n* Diagnosis of secondary hypertension\n* Diagnosis of or possible concomitant heart failure, with ejection fraction ≤50%\n* Paroxysmal, persistent, or permanent atrial fibrillation\n* Status post CABG or PCI\n* Structural heart disease\n* Risk of ventricular tachyarrhythmia\n* Severe hepatic or renal dysfunction\n* Active acute infection\n* Inability to sign informed consent\n* Pregnancy or planned pregnancy during the study period\n* Enrollment in other clinical studies that may affect the objectives of this study","65 Years",{"count":78,"type":20},70,[23],"The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. In the control group, the pacing lower rate will be set to the nominal 60 bpm post a dual-chamber pacemaker implantation as frequently used in clinical practice, while in the allometric-pace group, the pacing rate will be programmed at 75 bpm based on the estimation for Chinese population with a height of 165-170 cm (also called personalized lower rate) or based on the symptom-relief per clinical assessment by the study physicians. Each patient will undergo baseline assessments and 3-month follow-up visits. At the enrollment and office visits, each patient will undergo arterial blood pressure measurement, cardiac functional assessment and cerebral blood flow measurement. At the end of the study, the study physician will adjust pacing lower rate based on patients' conditions and clinical assessments. After the completion of the study, all patients will have regular device follow-up visit, usually 6-month interval or annually.\n\nEach patient will receive the following major assessments: device performance and pacing percentages, ventricular diastolic function by doppler and echocardiography of LVEF, LVEDV, LVESV, stroke volume, cardiac output, arterial blood pressure measurements, cerebral blood flow by MRI or Echo (which one will be determined later by the study PIs), and Mini-Mental State Examination (MMSE).",[82],"Bradycardia","2026-05-09",{"date":85,"type":32},"2026-05-15",{"date":85,"type":20},{"date":88,"type":20},"2028-05-31",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100573399","evolution-of-intracardiac-electrograms-recorded-by-left-bundle-branch-pacing-lead-in-patients-with-icd-or-crt-d-100573399","NCT06745778","Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D","Inclusion Criteria:\n\n* Patients aged \\>=18 yrs.\n* Patients indicated for ICD or CRT-D (primary or secondary prevention)\n* Patients who recently (\\\u003C=30 days) received ICD\u002FCRT-D implantation with LBBP\n* Patients' EGM can be digitally recorded\n* Patients are willing to participate in the study and provide signed informed consent\n\nExclusion Criteria:\n\n* Patients received CIED upgrade or replacement with old pacing leads\n* Patients are pregnant\n* Patients participate in another study that will confound this study",{"count":97,"type":20},50,"OBSERVATIONAL","The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD\u002FCRT-D patients. The main question it aims to answer is:\n\n• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD\u002FCRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.",[101,102],"Ventricular Tachycardia (VT)","Ventricular Fibrillation","2026-05-06",{"date":105,"type":32},"2026-05-08",{"date":107,"type":32},"2025-02-26",{"date":109,"type":20},"2026-07-31",{"name":38,"class":39},2,{"id":113,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":124,"locationsCount":4},"100633454",{"count":115,"type":20},80,[23],"This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ).",[26,27],"2026-04-23",{"date":121,"type":32},"2026-04-28",{"date":34,"type":20},{"date":36,"type":20},{"name":38,"class":39},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100503782","fast-induced-remodeling-in-heart-failure-with-preserved-ejection-fraction-100503782","NCT05839730","Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction","FIRE-HFpEF","Inclusion Criteria:\n\n* Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year).\n* New York Heart Association (NYHA) Functional Class I-III\n* Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the exception of loop diuretic therapy. GDMT should be in accordance with current American Heart Association (AHA)\u002FAmerican College of Cardiology (ACC)\u002FHeart Failure Society of America (HFSA) Guidelines and include consideration of Sodium\u002Fglucose cotransporter-2 inhibitors (SGLT2i) therapy.\n* V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL\u002Fm\\^2.\n* Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:\n\n  * Left ventricular (LV) posterior or lateral wall thickness \\> 11mm\n  * Relative wall thickness (RWT) \\> 0.42\n  * Male and LV mass indexed to BSA ≥115 g\u002Fm2\n  * Male and LV mass indexed to height ≥ 49.2 g\u002Fm2.7\n  * Female and LV mass indexed to BSA ≥ 95 g\u002Fm2\n  * Female and LV mass indexed to height ≥ 46.7 g\u002Fm2.7\n\nExclusion Criteria:\n\n* Unable or unwilling to undergo contrast MRI.\n* Class I indication for permanent pacing, except for symptomatic chronotropic incompetence\n* Current permanent or persistent Atrial fibrillation (A-fib)\n* Structural heart disease requiring intervention\n* Aortic valve replacement procedure less than 12 months prior to enrollment\n* Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy\n* Severe aortic or mitral valve disease, defined as severe regurgitation or a valve area \\\u003C 1cm\\^2\n* Exertional angina\n* Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalized for pulmonary decompensation within 12 months)\n* Estimated glomerular filtration rate (eGFR) \\\u003C 25 ml\u002Fmin\u002F1.73m\\^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula\n* Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.",{"count":133,"type":20},105,[23],"FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.",[137,58],"Heart Failure With Preserved Ejection Fraction",{"date":139,"type":32},"2026-04-27",{"date":141,"type":32},"2024-09-11",{"date":143,"type":20},"2027-07",{"name":38,"class":39},8,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":111},"100557623","bolt-csp-m-holter-study-100557623","NCT06540521","Bolt CSP-M Holter Study","Intracardiac Electrical Characteristics of LBBAP","Inclusion Criteria:\n\n* Patients aged \\>=18 years\n* Patients who are willing to provide Informed Consent\n* Patients who have received LBBAP therapy \\>= 1 month for 1 to 4 months (including 1 and 4 month)\n* Patients implanted with a single\u002Fdual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port\n* Implanted device can provide at least 3-channel real-time intracardiac electrogram\n\nExclusion Criteria:\n\n* Patients who are pregnant or have a plan for pregnancy during the study\n* Patients who have medical conditions that would limit study participation\n* Patients who were already enrolled in clinical trial(s) which would impact study participation",{"count":154,"type":20},75,"The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.",[26,82],[158,159,160],"LBBAP","LBBP","LVSP","2025-09-23",{"date":163,"type":32},"2025-09-29",{"date":165,"type":32},"2024-08-13",{"date":167,"type":20},"2026-06-30",{"name":38,"class":39},""]