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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to assist people with heart failure and atrial fibrillation, a type of irregular heart rhythm. One group will receive a treatment called BiV pacing, while another will try LBBAP (Left Bundle Branch Area Pacing). Both groups will undergo AV node ablation to help manage heart rhythm. This trial suits individuals who have not found success with other heart treatments and are considering AV node ablation. As an unphased trial, it provides a unique opportunity to explore innovative treatments for heart rhythm management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should be on optimal heart failure therapies for at least 4 weeks, which suggests you may need to continue your current heart failure treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Left Bundle Branch Area Pacing (LBBAP) is generally safe and well-tolerated. Studies indicate it achieves high success rates and maintains acceptable complication rates, even when performed by less experienced doctors. This treatment often addresses conditions like a slow heart rate and heart failure.

For Cardiac Resynchronization Therapy (CRT), research has found it effective in reducing the risk of heart failure events. It also lowers the chances of death and hospital readmissions compared to medication alone. However, about 30% of patients may not experience improvements with CRT.

Both treatments have demonstrated promising safety records, although individual responses can vary. Always consult a healthcare provider to understand what these findings mean for personal health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for heart failure because they offer unique approaches to improving heart function. Unlike traditional Cardiac Resynchronization Therapy (CRT), which uses a combination of electrical pacing and AV node ablation to synchronize the heart's ventricles, Left Bundle Branch Area Pacing (LBBAP) targets the heart's conduction system more naturally. This method aims to mimic the heart's normal electrical pathway, potentially leading to better heart performance and fewer complications. By refining the way electrical impulses are delivered, LBBAP could offer a more efficient and effective option for patients with heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that Left Bundle Branch Area Pacing (LBBAP), which participants in this trial may receive, is a promising treatment for heart failure. Studies have found that LBBAP can help manage heart rhythms and improve heart function, especially for patients who do not benefit from traditional treatments like cardiac resynchronization therapy (CRT). In this trial, one group will receive LBBAP followed by AV node ablation, while another group will receive CRT followed by AV node ablation. LBBAP is widely used due to its high success rates and acceptable safety. Clinical findings indicate that LBBAP can be a reliable option for people with heart failure, with positive results reported in various trials. These studies suggest that LBBAP could be a strong alternative for heart failure patients who need pacing treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Habib Khan, MBBS, PhD

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. academic.oup.com academic.oup.com/europace/article/27/8/euaf181/8242754

Two-year outcomes of left bundle branch area pacing versus ... This registry-based trial compared left bundle branch area pacing (LBBAP) with RVP in patients younger than 65 years. Methods and results. Using ...

2. hrsonline.org hrsonline.org/news/lcbt-showcase-promising-outcomes-left-bundle-branch-area-pacing/

Late-Breaking Clinical Trials at Heart Rhythm 2025 ... Findings from two late-breaking clinical trials demonstrate the safety and efficacy of left bundle branch area pacing (LBBAP), adding to the growing body of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8636235/

Outcomes of Left Bundle Branch Area Pacing for Cardiac ... LBBAP might be a reasonable option for patients who meet indications for CRT, particularly in those who have limited anatomy or do not benefit from CRT.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0167527324015018

Real-world adoption of left bundle branch area pacing LBBAP is routinely adopted for bradycardia and heart failure indication, with high success and acceptable complication rates, even when performed by less ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07069738

Safety and Effectiveness of Left Bundle Branch Area ... This study will compare two different methods to pace the heart to treat heart failure including: The current standard method of implanting a pacing lead in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7472379/

Efficacy and Safety of Exercise Rehabilitation for Heart Failure ... Conclusions: Exercise rehabilitation may restore exercise capacity and cardiac function in HF patients with a CRT device. Furthermore, exercise ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906431

Cardiac-Resynchronization Therapy for the Prevention of ... The superiority of CRT was driven by a 41% reduction in the risk of heart-failure events, a finding that was evident primarily in a prespecified subgroup of ...

8. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.113.000838

Clinical Effectiveness of Cardiac Resynchronization ... CRT-D was associated with lower risks of mortality, all-cause readmission, and cardiovascular readmission than medical therapy alone among patients with heart ...

9. jacc.org jacc.org/doi/10.1016/j.jacep.2020.11.010

Redefining the Classifications of Response to Cardiac ... However, approximately 30% of patients do not improve with CRT by various metrics, and they are traditionally classified as nonresponders.

10. mdpi.com mdpi.com/2077-0383/14/19/6766

Cardiac Rehabilitation in the Era of CRT and ARNI Patients treated with either CRT or ARNI showed consistent improvements when CR was incorporated into their care. For CRT patients, the combination of improved ...