LBBAP vs BiV Pacing for Heart Failure

(RAFT-P&A Trial)

Overseen By Abbie Barron

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Habib Khan

Must be taking: Heart failure therapies

Disqualifiers: Acute illness, Coronary syndrome, Valvular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1-4 weeks

284 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Habib Khan, MBBS, PhD

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for heart failure patients with atrial fibrillation who can't use rhythm control and are on stable heart failure medication. It's also for those who've had a failed ablation, can't tolerate certain drugs, or choose not to have rhythm control strategies. People with recent severe cardiac events, certain types of cardiomyopathy, severe lung disease, or life expectancy less than one year due to non-cardiac causes cannot join.

Inclusion Criteria

I have had at least one unsuccessful ablation treatment.

I choose not to undergo treatments to correct my heart rhythm.

I have been on heart failure medication for at least 4 weeks.

Exclusion Criteria

I am hospitalized with a serious illness needing intensive care.

I have a specific heart condition affecting my heart's structure or function.

I have a serious heart valve problem that can't be fixed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either CRT or LBBAP followed by AV node ablation

1-4 weeks

1 visit (in-person) for procedure, 1 visit (in-person) for follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 6 and 12 months

Treatment Details

Interventions

• AV node ablation
• CRT
• Left Bundle Branch Area Pacing

Trial Overview The study compares two treatments for managing heart failure in patients with atrial fibrillation: the standard BiV pacing followed by AV node ablation versus the experimental Left Bundle Branch Area Pacing (LBBAP) followed by AV node ablation.

Participant Groups

Group I: Left Bundle Branch Area Pacing + AV node ablation Experimental Treatment 2 Interventions

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

Group II: Cardiac Resynchronization Therapy + AV node ablation Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Habib Khan

Lead Sponsor

Trials

4

Recruited

520+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+