Back to resultsLVSP Based CRT vs. RVAP Based CRT
Primary Purpose
Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Septal Pacing
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
left ventricular septal pacing
right ventricular apical pacing
Sponsored by
About this trial
This is an interventional treatment trial for 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: Previous mechanical tricuspid valve replacement. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%. Patients participated in any of the other studies at the same time, which may confound the results of this study. Pregnancy, planning to become pregnant. 8. Patients with a history of heart transplantation.
Sites / Locations
- Fuwai hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LVSP-CRT
RVAP-CRT
Arm Description
Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.
Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.
Outcomes
Primary Outcome Measures
left ventricular ejection fraction (LVEF)
LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular ejection fraction (LVEF)
LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular end-systolic volume (LVESV)
LVESV evaluated by echocardiography
left ventricular end-systolic volume (LVESV)
LVESV evaluated by echocardiography
Secondary Outcome Measures
paced QRSd duration.
QRS duration measurement after the procedure
paced QRSd duration.
QRS duration measurement after the procedure
NT-proBNP
Serum NT-proBNP level
NT-proBNP
Serum NT-proBNP level
6-minute hall walk distance
6-minute hall walk distance
6-minute hall walk distance
6-minute hall walk distance
Heart failure rehospitalization
Rehospitalization due to the exacerbation of heart failure
Heart failure rehospitalization
Rehospitalization due to the exacerbation of heart failure
Rehospitalization for cardiovascular adverse events
Rehospitalization for cardiovascular adverse events
Malignant ventricular arrhythmias
ICD therapy for ventricular tachycardia or ventricular fibrillation
Malignant ventricular arrhythmias
ICD therapy for ventricular tachycardia or ventricular fibrillation
All cause death
All cause death events
All cause death
All cause death events
Full Information
NCT ID
NCT05985408
First Posted
August 3, 2023
Last Updated
August 3, 2023
Sponsor
Fu Wai Hospital, Beijing, China
1. Study Identification
Unique Protocol Identification Number
NCT05985408
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Wai Hospital, Beijing, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Septal Pacing, Right Ventricular Septal Pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LVSP-CRT
Arm Type
Experimental
Arm Description
Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.
Arm Title
RVAP-CRT
Arm Type
Active Comparator
Arm Description
Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.
Intervention Type
Device
Intervention Name(s)
left ventricular septal pacing
Intervention Description
For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.
Intervention Type
Device
Intervention Name(s)
right ventricular apical pacing
Intervention Description
For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.
Primary Outcome Measure Information:
Title
left ventricular ejection fraction (LVEF)
Description
LVEF evaluated by echocardiography，Bi-plane Simpson's method
Time Frame
6 months
Title
left ventricular ejection fraction (LVEF)
Description
LVEF evaluated by echocardiography，Bi-plane Simpson's method
Time Frame
12 months
Title
left ventricular end-systolic volume (LVESV)
Description
LVESV evaluated by echocardiography
Time Frame
6 months
Title
left ventricular end-systolic volume (LVESV)
Description
LVESV evaluated by echocardiography
Time Frame
12 months
Secondary Outcome Measure Information:
Title
paced QRSd duration.
Description
QRS duration measurement after the procedure
Time Frame
6 months
Title
paced QRSd duration.
Description
QRS duration measurement after the procedure
Time Frame
12 months
Title
NT-proBNP
Description
Serum NT-proBNP level
Time Frame
6 months
Title
NT-proBNP
Description
Serum NT-proBNP level
Time Frame
12 months
Title
6-minute hall walk distance
Description
6-minute hall walk distance
Time Frame
6 months
Title
6-minute hall walk distance
Description
6-minute hall walk distance
Time Frame
12 months
Title
Heart failure rehospitalization
Description
Rehospitalization due to the exacerbation of heart failure
Time Frame
6 months
Title
Heart failure rehospitalization
Description
Rehospitalization due to the exacerbation of heart failure
Time Frame
12 months
Title
Rehospitalization for cardiovascular adverse events
Description
Rehospitalization for cardiovascular adverse events
Time Frame
12 months
Title
Malignant ventricular arrhythmias
Description
ICD therapy for ventricular tachycardia or ventricular fibrillation
Time Frame
6 months
Title
Malignant ventricular arrhythmias
Description
ICD therapy for ventricular tachycardia or ventricular fibrillation
Time Frame
12 months
Title
All cause death
Description
All cause death events
Time Frame
6 months
Title
All cause death
Description
All cause death events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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:
Previous mechanical tricuspid valve replacement.
Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
Patients participated in any of the other studies at the same time, which may confound the results of this study.
Pregnancy, planning to become pregnant.
8. Patients with a history of heart transplantation.
Facility Information:
Facility Name
Fuwai hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Li, Doctor
Phone
17801013995
Email
lixiaofei0103@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
37211145
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.
Results Reference
result
PubMed Identifier
36704478
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.
Results Reference
result
PubMed Identifier
33930549
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.
Results Reference
result
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LVSP Based CRT vs. RVAP Based CRT
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