Left Bundle Branch Pacing (LBBP) for the Treatment of Cardiac Dysfunction With Safety and Efficacy Study in Patients With Atrioventricular Block

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05793502

Collaborator

(none)

160

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study periodically assessed patients' cardiac function and prognosis by cardiac ultrasound, NYHA cardiac function class, 6-minute walk distance, quality of life score (QoL), and clinical events at follow-up, with the aim of assessing whether LBBP is no less effective than CRT in patients with left ventricular ejection fraction (LVEF) <50% and estimated percentage of ventricular pacing >40% of cardiac dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Consented to Participate in the Trial and Signed an Informed Consent Form NYHA Heart Function Classification of I-III	Device: LBBP/CRT

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

160 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Left Bundle Branch Pacing (LBBP) for the Treatment of Cardiac Dysfunction With Safety and Efficacy Study in Patients With Atrioventricular Block

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Mar 20, 2025

Anticipated Study Completion Date :

Mar 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
LBBP	Device: LBBP/CRT The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio
CRT	Device: LBBP/CRT The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio

Arm

Intervention/Treatment

LBBP

Device: LBBP/CRT

The trial plans to enroll 160 patients with cardiac dysfunction who meet the enrollment criteria and agree to participate in the trial, and randomly assign them to the LBBP and CRT groups in a 1:1 ratio

CRT

Device: LBBP/CRT

Outcome Measures

Primary Outcome Measures

12 months of LVEF [12 months]
LVEF at 12 months after implantation was analyzed to compare the LBBP treatment group with the CRT treatment group for the target subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be at least 18 years of age.
Consent to participate in the trial and have signed an informed consent form.
NYHA cardiac function classification of I-III.
LVEF < 50%.
Ventricular pacing-dependent patients with second-degree or complete AV block with pacing indications or ventricular pacing percentage >40%.
Patients who are willing to implant a new implant or have their device replaced or upgraded.

Exclusion Criteria:

Life expectancy <1 year.
Patients with severe tricuspid valve disease1 or who have undergone mechanical or bioprosthetic valve surgery.
have had an acute myocardial infarction within 1 month
Women of childbearing potential who are pregnant or who become pregnant during the study period.
Severe hepatic or renal dysfunction.
Have been enrolled in other clinical studies that may interfere with the objectives of this trial.
Have evidence of severe pulmonary hypertension (PASP > 70 mmHg).
Have evidence of hypertrophic cardiomyopathy that would affect the patient's prognosis.
Subjects who, in the opinion of the investigator, are physically unfit to participate in this trial.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Keping, Chief physician, Chinese Academy of Medical Sciences, Fuwai Hospital

ClinicalTrials.gov Identifier:

NCT05793502

Other Study ID Numbers:

20230320

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Atrioventricular Block

Study Results

No Results Posted as of Mar 31, 2023