LVSP Based CRT vs. RVAP Based CRT

August 3, 2023 updated by: Li Xiaofei, Fu Wai Hospital, Beijing, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LVSP-CRT
Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.
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.
Active Comparator: RVAP-CRT
Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular ejection fraction (LVEF)
Time Frame: 6 months
LVEF evaluated by echocardiography，Bi-plane Simpson's method
6 months
left ventricular ejection fraction (LVEF)
Time Frame: 12 months
LVEF evaluated by echocardiography，Bi-plane Simpson's method
12 months
left ventricular end-systolic volume (LVESV)
Time Frame: 6 months
LVESV evaluated by echocardiography
6 months
left ventricular end-systolic volume (LVESV)
Time Frame: 12 months
LVESV evaluated by echocardiography
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
paced QRSd duration.
Time Frame: 6 months
QRS duration measurement after the procedure
6 months
paced QRSd duration.
Time Frame: 12 months
QRS duration measurement after the procedure
12 months
NT-proBNP
Time Frame: 6 months
Serum NT-proBNP level
6 months
NT-proBNP
Time Frame: 12 months
Serum NT-proBNP level
12 months
6-minute hall walk distance
Time Frame: 6 months
6-minute hall walk distance
6 months
6-minute hall walk distance
Time Frame: 12 months
6-minute hall walk distance
12 months
Heart failure rehospitalization
Time Frame: 6 months
Rehospitalization due to the exacerbation of heart failure
6 months
Heart failure rehospitalization
Time Frame: 12 months
Rehospitalization due to the exacerbation of heart failure
12 months
Rehospitalization for cardiovascular adverse events
Time Frame: 12 months
Rehospitalization for cardiovascular adverse events
12 months
Malignant ventricular arrhythmias
Time Frame: 6 months
ICD therapy for ventricular tachycardia or ventricular fibrillation
6 months
Malignant ventricular arrhythmias
Time Frame: 12 months
ICD therapy for ventricular tachycardia or ventricular fibrillation
12 months
All cause death
Time Frame: 6 months
All cause death events
6 months
All cause death
Time Frame: 12 months
All cause death events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Wai Hospital, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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