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Procedure

LBBAP vs BiV Pacing for Heart Failure (RAFT-P&A Trial)

N/A
Waitlist Available
Led By Habib Khan, MBBS, PhD
Research Sponsored by Habib Khan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed Ablation (≥1 failed ablation attempt)
Refractory or intolerant to Antiarrhythmic drugs AADs or rate control medications
Must not have
In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trialcompares two strategies for treating heart failure & atrial fibrillation. One group gets BiV pacing + AV ablation; the other, LBBAP + AV ablation.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications from device implantation like infection or bleeding, issues related to ineffective pacing such as worsening heart failure symptoms, and risks associated with AV node ablation including pacemaker dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one unsuccessful ablation treatment.
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My body does not respond to or cannot tolerate heart rhythm medications.
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My heart condition ranges from no symptoms to severe limitations.
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I have atrial fibrillation and may need a procedure to regulate my heart rhythm, possibly with a pacemaker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am hospitalized with a serious illness needing intensive care.
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I have a specific heart condition affecting my heart's structure or function.
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I have a serious heart valve problem that can't be fixed.
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My doctor expects I have less than a year to live due to my cancer.
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My heart condition severely limits my physical activity.
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I have high blood pressure in the lungs.
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I have had a heart attack or heart surgery in the last 3 months.
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I have severe lung disease and need inhalers or oxygen.
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I can give consent myself or have someone legally authorized to do so.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in NT-proBNP from baseline to 6-month follow-up
Secondary study objectives
Change 6MWT distance
Change in QoL - EQ-5D
Change in QoL - KCCQ
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Left Bundle Branch Area Pacing + AV node ablationExperimental Treatment2 Interventions
The experimental group will be treated with LBBAP followed by an Atrioventricular Node Ablation.
Group II: Cardiac Resynchronization Therapy + AV node ablationActive Control2 Interventions
The active comparator group will be treated with CRT followed by an Atrioventricular Node Ablation.

Find a Location

Who is running the clinical trial?

Habib KhanLead Sponsor
2 Previous Clinical Trials
86 Total Patients Enrolled
London Health Sciences CentreOTHER
148 Previous Clinical Trials
56,950 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
194 Patients Enrolled for Atrial Fibrillation
Habib Khan, MBBS, PhDPrincipal InvestigatorLondon Health Sciences Centre

Media Library

AV node ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05428787 — N/A
Atrial Fibrillation Research Study Groups: Cardiac Resynchronization Therapy + AV node ablation, Left Bundle Branch Area Pacing + AV node ablation
Atrial Fibrillation Clinical Trial 2023: AV node ablation Highlights & Side Effects. Trial Name: NCT05428787 — N/A
AV node ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05428787 — N/A
~90 spots leftby Dec 2025
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