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LBBAP vs BiV Pacing for Heart Failure (RAFT-P&A Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 12 months
Awards & highlights
RAFT-P&A Trial 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.Check my eligibility
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.See study design
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.
RAFT-P&A Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
RAFT-P&A Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in NT-proBNP from baseline to 6-month follow-up
Secondary outcome measures
Change 6MWT distance
Change in QoL - EQ-5D
Change in QoL - KCCQ
+6 moreRAFT-P&A 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
143 Previous Clinical Trials
49,674 Total Patients Enrolled
Habib Khan, MBBS, PhDPrincipal InvestigatorLondon Health Sciences Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had at least one unsuccessful ablation treatment.You had a transcatheter aortic valve implantation (TAVI) less than 3 months ago.My doctor expects I have less than a year to live due to my cancer.You are currently participating in another clinical trial that could interfere with this study.You are not expected to live more than a year due to a non-heart related condition.I choose not to undergo treatments to correct my heart rhythm.My heart condition severely limits my physical activity.I have high blood pressure in the lungs.I have had a heart attack or heart surgery in the last 3 months.I have been on heart failure medication for at least 4 weeks.I'm not familiar with the abbreviation "AVNA." Could you please provide more context or clarify what it stands for?I have severe lung disease and need inhalers or oxygen.My body does not respond to or cannot tolerate heart rhythm medications.My heart condition ranges from no symptoms to severe limitations.My treatment is focused on controlling my heart rate, not its rhythm.I can give consent myself or have someone legally authorized to do so.I have atrial fibrillation and may need a procedure to regulate my heart rhythm, possibly with a pacemaker.Your NT-proBNP level is higher than 600, or higher than 400 if you've been hospitalized for heart failure in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac Resynchronization Therapy + AV node ablation
- Group 2: Left Bundle Branch Area Pacing + AV node ablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study currently have open enrollment?
"According to clinicaltrials.gov, the research is still actively seeking participants; it was originally advertised on September 26th 2022 and recently updated on January 14th 2023."
Answered by AI
Does the trial accept individuals below a certain age threshold?
"As per the inclusion criteria, this clinical trial is available to participants aged between 18 and 90 years. Additionally, there are 43 trials for minors under 18 as well 1244 studies targeting individuals over 65."
Answered by AI
How many participants are taking part in this trial?
"Affirmative. The clinicaltrials.gov page displays that this study is actively seeking suitable participants, having been first posted on September 26th 2022 and most recently updated on January 14th 2023. This trial requires 284 individuals to be recruited from 1 medical facility."
Answered by AI
Is there a way for me to engage in this experiment?
"This trial is recruiting a cohort of 284 individuals between 18 and 90 years old, suffering from heart failure. To qualify for the study, candidates must have atrial fibrillation (AF) which requires AVNA with or without a pacemaker; be on optimal HF therapies for 4 weeks minimum; demonstrate NYHA class I-IVa severity levels; failed ablation attempts in the past year; refused/intolerant to AADs and rate control medications as well as rhythm control strategies; baseline NT-proBNP>600 or >400 if hospitalized due to HF within 12 months prior."
Answered by AI
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