Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing

NCT05428787 | Active Not Recruiting

• 1 other identifier: 3819
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will compare two management strategies for HF patients with Atrial Fibrillation. The active control group will undergo BiV pacing, followed by an AV node ablation. The experimental group will undergo LBBAP, followed by an AV node ablation.

Conditions

Atrial Fibrillation; Heart Failure; Cardiomyopathies

Keywords

LBBAP; Conductions system pacing; atrial fibrillation; pace and ablate; AV node ablation; CRT; BiV-CRT

Outcome Measures

Primary Outcomes (1)

• Change in NT-proBNP from baseline to 6-month follow-up

  Comparison between NT-proBNP measurement at baseline and 6-month follow-up

  baseline and 6 months

Secondary Outcomes (9)

• Event rates of the composite outcome of heart failure events and all-cause mortality

  12 months

• Change in QoL - MLHFQ

  baseline, 6 months and 12 months

• Change in QoL - KCCQ

  baseline, 6 months and 12 months

• Change in QoL - EQ-5D

  baseline, 6 months and 12 months

• Change 6MWT distance

  baseline, 6 months and 12 months

Study Arms (2)

Cardiac Resynchronization Therapy + AV node ablation

ACTIVE COMPARATOR

The active comparator group will be treated with CRT followed by an Atrioventricular Node Ablation.

Procedure: CRT; Procedure: AV node ablation

Left Bundle Branch Area Pacing + AV node ablation

EXPERIMENTAL

The experimental group will be treated with LBBAP followed by an Atrioventricular Node Ablation.

Procedure: Left Bundle Branch Area Pacing; Procedure: AV node ablation

Interventions

Left Bundle Branch Area Pacing PROCEDURE

The patients will be allocated by randomization to receive the intervention of Left Bundle Branch Area Pacing

Also known as: LBBAP

Left Bundle Branch Area Pacing + AV node ablation

CRT PROCEDURE

The patients will be allocated by randomization to receive the intervention of CRT.

Cardiac Resynchronization Therapy + AV node ablation

AV node ablation PROCEDURE

AV node ablation after 4 weeks of CRT implant or LBBAP implant.

Cardiac Resynchronization Therapy + AV node ablation; Left Bundle Branch Area Pacing + AV node ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with atrial fibrillation (AF) where AVNA is being considered with or without a pacemaker
• Are on optimal heart failure therapies for ≥4 weeks
• NYHA class I-IVa
• Patients deemed not appropriate for rhythm control strategy (only for rate control strategy).
• Failed Ablation (≥1 failed ablation attempt)
• Refractory or intolerant to Antiarrhythmic drugs AADs or rate control medications
• Patient choice not to have rhythm control strategies
• Being considered for AVNA
• Patients with baseline NT-proBNP\>600 or \>400 if HF hospitalization within 12 months.

You may not qualify if:

• In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
• Acute coronary syndrome (including MI) or Coronary revascularization (CABG or PCI) \<3 months
• Uncorrected or uncorrectable primary moderate to severe valvular disease
• TAVI \< 3 months
• Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
• Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
• Pulmonary hypertension (Mean pulmonary pressure is ≥35 mm Hg)
• Patients with a life expectancy of less than one year from non-cardiac cause
• Patients included in other clinical trials that will affect the objectives of this study or have competing interests
• Those unable or unwilling to provide informed consent unless supported by legal power of attorney
• Active malignancy with likelihood of survival \<1 year
• NYHA class IVb

Sponsors & Collaborators

• Habib Khan: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Habib Khan, MBBS, PhD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 23, 2022
• Study Start: September 26, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)