LVSP Based CRT vs. RVAP Based CRT

Heart Failure Clinical Trial

Official title:

Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05985408
• Other study ID #: 2023-0801
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2023
• Source: Fu Wai Hospital, Beijing, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure
• Left Ventricular Septal Pacing

Intervention

Device:
• left ventricular septal pacing
For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.
• right ventricular apical pacing
For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Wai Hospital, Beijing, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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 ventricula — View 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-Te — View 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular ejection fraction (LVEF)	LVEF evaluated by echocardiography,Bi-plane Simpson's method	6 months
Primary	left ventricular ejection fraction (LVEF)	LVEF evaluated by echocardiography,Bi-plane Simpson's method	12 months
Primary	left ventricular end-systolic volume (LVESV)	LVESV evaluated by echocardiography	6 months
Primary	left ventricular end-systolic volume (LVESV)	LVESV evaluated by echocardiography	12 months
Secondary	paced QRSd duration.	QRS duration measurement after the procedure	6 months
Secondary	paced QRSd duration.	QRS duration measurement after the procedure	12 months
Secondary	NT-proBNP	Serum NT-proBNP level	6 months
Secondary	NT-proBNP	Serum NT-proBNP level	12 months
Secondary	6-minute hall walk distance	6-minute hall walk distance	6 months
Secondary	6-minute hall walk distance	6-minute hall walk distance	12 months
Secondary	Heart failure rehospitalization	Rehospitalization due to the exacerbation of heart failure	6 months
Secondary	Heart failure rehospitalization	Rehospitalization due to the exacerbation of heart failure	12 months
Secondary	Rehospitalization for cardiovascular adverse events	Rehospitalization for cardiovascular adverse events	12 months
Secondary	Malignant ventricular arrhythmias	ICD therapy for ventricular tachycardia or ventricular fibrillation	6 months
Secondary	Malignant ventricular arrhythmias	ICD therapy for ventricular tachycardia or ventricular fibrillation	12 months
Secondary	All cause death	All cause death events	6 months
Secondary	All cause death	All cause death events	12 months