NCT05985408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

August 3, 2023

Last Update Submit

August 3, 2023

Conditions

Heart FailureCardiac Resynchronization TherapyLeft Ventricular Septal PacingRight Ventricular Septal Pacing

Outcome Measures

Primary Outcomes (4)

  • left ventricular ejection fraction (LVEF)

    LVEF evaluated by echocardiography，Bi-plane Simpson's method

    6 months

  • left ventricular ejection fraction (LVEF)

    LVEF evaluated by echocardiography，Bi-plane Simpson's method

    12 months

  • left ventricular end-systolic volume (LVESV)

    LVESV evaluated by echocardiography

    6 months

  • left ventricular end-systolic volume (LVESV)

    LVESV evaluated by echocardiography

    12 months

Secondary Outcomes (13)

  • paced QRSd duration.

    6 months

  • paced QRSd duration.

    12 months

  • NT-proBNP

    6 months

  • NT-proBNP

    12 months

  • 6-minute hall walk distance

    6 months

  • +8 more secondary outcomes

Study Arms (2)

LVSP-CRT

EXPERIMENTAL

Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.

Device: left ventricular septal pacing

RVAP-CRT

ACTIVE COMPARATOR

Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.

Device: right ventricular apical pacing

Interventions

left ventricular septal pacingDEVICE

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

LVSP-CRT
right ventricular apical pacingDEVICE

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

RVAP-CRT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.
  • \. Patients with a history of heart transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (3)

  • 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.

    PMID: 37211145RESULT

  • 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.

    PMID: 36704478RESULT

  • 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.

    PMID: 33930549RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

CN(1)