Clinical trial NCT05985408: LVSP Based CRT vs. RVAP Based CRT
Official title: Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Left Ventricular Septal Pacing
Right Ventricular Septal Pacing
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.


Eligibility criteria: Inclusion Criteria:

1. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.

Exclusion Criteria:

1. Previous mechanical tricuspid valve replacement.
2. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
3. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
4. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
5. Patients participated in any of the other studies at the same time, which may confound the results of this study.
6. Pregnancy, planning to become pregnant.

8. Patients with a history of heart transplantation.

Primary outcomes:
measure: left ventricular ejection fraction (LVEF)
timeFrame: 6 months
measure: left ventricular ejection fraction (LVEF)
timeFrame: 12 months
measure: left ventricular end-systolic volume (LVESV)
timeFrame: 6 months
measure: left ventricular end-systolic volume (LVESV)
timeFrame: 12 months
Secondary outcomes:
measure: paced QRSd duration.
timeFrame: 6 months
measure: paced QRSd duration.
timeFrame: 12 months
measure: NT-proBNP
timeFrame: 6 months
measure: NT-proBNP
timeFrame: 12 months
measure: 6-minute hall walk distance
timeFrame: 6 months
measure: 6-minute hall walk distance
timeFrame: 12 months
measure: Heart failure rehospitalization
timeFrame: 6 months
measure: Heart failure rehospitalization
timeFrame: 12 months
measure: Rehospitalization for cardiovascular adverse events
timeFrame: 12 months
measure: Malignant ventricular arrhythmias
timeFrame: 6 months
measure: Malignant ventricular arrhythmias
timeFrame: 12 months
measure: All cause death
timeFrame: 6 months
measure: All cause death
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References:
citation: Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.
citation: Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022.
citation: Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28.