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Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure (LBBAP-AFHF)

Primary Purpose

Left Bundle Branch Area Pacing, Biventricular Pacing, Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Left bundle branch area pacing

Biventricular pacing

About this trial

This is an interventional treatment trial for Left Bundle Branch Area Pacing focused on measuring Left Bundle Branch Area Pacing, Permanent Atrial Fibrillation, Heart Failure, Biventricular Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients aged more than 18 years old
Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months
Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:
1. LVEF<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures
2. LVEF<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40%
Written informed consent was provided

Exclusion Criteria:

expected survival time is less than 12 months
Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)
Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months
Surgery is required within 1 year due to severe structural heart disease
Pregnancy, planned pregnancy or heart transplant
Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure.
Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another

Sites / Locations

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical SciencesRecruiting
Peking University First Hospital
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
The Second Hospital of Hebei Medical University
The first affiliated hospital of Nanjing medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LBBAP group

BiVP group

Arm Description

Device: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration.

Device: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule.

Outcomes

Primary Outcome Measures

ΔLVEF between baseline and six months post-discharge

ΔLVEF：change in LVEF between baseline and six months after procedure

Secondary Outcome Measures

The immediate success rate of the LBBAP procedure

Successful LBBAP procedure is identified according to ECG and intracardiac ECG electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP).

The rate of procedure and Device related complications

Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications

ΔLVEDD between baseline and six months post-discharge

ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups

ΔLVEDV between baseline and six months post-discharge

ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups

The echocardiographic response rate of LVEF increase ≥5%

the percentage of patients with change of LVEF ≥5% at 6 month from baseline

The changes of NT-proBNP betwen baseline and 6 months post-discharge

Composite incidence rate of all-cause mortality and/or hospitalization for heart failure

All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.

The echocardiographic response rate of LVEF increase ≥15%

an increase in LVESV ≥15% during follow-up at 6 month compared with baseline

The rate of ΔLVESV ≥15% between baseline and six months post-discharge

the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline

Full Information

NCT ID

NCT05549544

First Posted

September 15, 2022

Last Updated

October 20, 2022

Sponsor

Fu Wai Hospital, Beijing, China

Collaborators

The Second Hospital of Hebei Medical University, The First Affiliated Hospital with Nanjing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University First Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05549544

Brief Title

Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure

Acronym

LBBAP-AFHF

Official Title

Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 18, 2022 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fu Wai Hospital, Beijing, China

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure

Detailed Description

LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Left Bundle Branch Area Pacing, Biventricular Pacing, Heart Failure, Permanent Atrial Fibrillation

Keywords

Left Bundle Branch Area Pacing, Permanent Atrial Fibrillation, Heart Failure, Biventricular Pacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LBBAP group

Arm Type

Experimental

Arm Description

Arm Title

BiVP group

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Left bundle branch area pacing

Intervention Description

Left bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block.

Intervention Type

Device

Intervention Name(s)

Biventricular pacing

Intervention Description

Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure

Primary Outcome Measure Information:

Title

ΔLVEF between baseline and six months post-discharge

Description

ΔLVEF：change in LVEF between baseline and six months after procedure

Time Frame

Six months after device implantation

Secondary Outcome Measure Information:

Title

The immediate success rate of the LBBAP procedure

Description

Time Frame

1 weeks

Title

The rate of procedure and Device related complications

Description

Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications

Time Frame

6 months

Title

ΔLVEDD between baseline and six months post-discharge

Description

ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups

Time Frame

6 months

Title

ΔLVEDV between baseline and six months post-discharge

Description

ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups

Time Frame

6 months

Title

The echocardiographic response rate of LVEF increase ≥5%

Description

the percentage of patients with change of LVEF ≥5% at 6 month from baseline

Time Frame

6 months

Title

The changes of NT-proBNP betwen baseline and 6 months post-discharge

Description

The changes of NT-proBNP betwen baseline and 6 months post-discharge

Time Frame

6 months

Title

Composite incidence rate of all-cause mortality and/or hospitalization for heart failure

Description

Time Frame

6 months

Title

The echocardiographic response rate of LVEF increase ≥15%

Description

an increase in LVESV ≥15% during follow-up at 6 month compared with baseline

Time Frame

6 months

Title

The rate of ΔLVESV ≥15% between baseline and six months post-discharge

Description

the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients aged more than 18 years old Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including: LVEF<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures LVEF<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40% Written informed consent was provided Exclusion Criteria: expected survival time is less than 12 months Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.) Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months Surgery is required within 1 year due to severe structural heart disease Pregnancy, planned pregnancy or heart transplant Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure. Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haojie Zhu, M.D

Phone

+8613167310573

13167310573@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaofei Li, M.D

Phone

+8617801013995

lixiaofei0103@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaohan Fan, PhD

Organizational Affiliation

Chinese Academy of Medical Sciences, Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haojie Zhu

Phone

+8613167310573

13167310573@163.com

First Name & Middle Initial & Last Name & Degree

Xiaofei Li

Phone

+8617801013995

lixiaofei0103@163.com

First Name & Middle Initial & Last Name & Degree

Xiaohan Fan

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing Zhou

Facility Name

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yangxin Chen

Facility Name

The Second Hospital of Hebei Medical University

City

Shijiazhuang

State/Province

Hebei

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruiqin Xie

ruiqin_xie@sina.com

Facility Name

The first affiliated hospital of Nanjing medical university

City

Nanjing

State/Province

Jiangsu

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiangang Zou

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure

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