Redo AF Ablation vs Pace and Ablate for Atrial Fibrillation

(REDO-AF Trial)

Overseen By Jacqueline Joza, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jacqueline Joza

Disqualifiers: Severe valvular disease, recent MI, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies per treatment strategy

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage recurring atrial fibrillation (AF) after previous treatments have failed. Participants will either undergo another AF ablation (Redo AF Ablation) or receive conduction system pacing with AV node ablation (Pace and Ablate), both aiming to improve heart rhythm. The trial examines how these treatments affect quality of life and assesses their feasibility for future studies. It suits individuals who have had at least one AF ablation, continue to experience symptoms, and have not responded well to medication. As an unphased trial, it offers participants the chance to contribute to valuable research that could shape future treatment options.

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

Research has shown that the "pace and ablate" strategy, which combines heart rhythm control with a procedure to block certain heart signals, is generally well-tolerated. Studies indicate it effectively manages heart rate in people with atrial fibrillation (AF) and can reduce hospital visits over time. One study found that permanent left bundle branch pacing was successful 100% of the time in some cases.

For the redo AF ablation approach, earlier research found this method also helps manage AF symptoms in patients who have had a previous ablation. However, like any procedure, it carries some risks, such as possible complications during or after the procedure. Despite this, many patients report improved quality of life and fewer symptoms after treatment.

Both treatments have demonstrated promising safety in previous studies, but individual experiences may vary. It's important to discuss potential risks and benefits with healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing Redo AF Ablation with the Pace and Ablate approach for atrial fibrillation because it could redefine how we treat this common heart rhythm disorder. Unlike traditional medication or initial ablation procedures, Redo AF Ablation offers a chance to refine and improve the success of previous ablation efforts. On the other hand, the Pace and Ablate method, particularly the use of left bundle branch pacing (LBBP) combined with AV node ablation, presents a novel approach by potentially ensuring more stable and regular heart rhythms. These strategies aim to enhance effectiveness and patient outcomes beyond what's currently possible with standard treatments like medication and initial ablation.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation?

This trial will compare two approaches for treating atrial fibrillation: Redo AF Ablation and the "pace and ablate" strategy. Research has shown that repeating an AF ablation procedure can help treat atrial fibrillation, with about 53% of patients experiencing no irregular heartbeat one year after the procedure, although about 32% had their AF symptoms return. Meanwhile, the "pace and ablate" strategy can help manage AF symptoms and reduce hospital visits, but it might make patients dependent on a pacemaker and can lead to a 12%–15% decrease in the amount of blood the heart pumps if the heart rhythm stays irregular. Both methods have their own benefits and risks, and their effectiveness can vary. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients who have symptomatic, drug-resistant recurrent atrial fibrillation and have had at least one prior AF ablation. It's designed to see which treatment works better after the first ablation didn't stop their AF.

Inclusion Criteria

Willingness to participate, complete the QOL questionnaires and ability to sign informed consent

I have had one or more procedures to treat atrial fibrillation.

I have ongoing heart rhythm problems despite treatment, following my last ablation over 2 months ago.

Exclusion Criteria

I am unable to understand and make decisions about my health care.

Life expectancy <24 months

My heart's pumping ability is low or I need a device to regulate my heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either redo AF ablation or LBBP + AV Node ablation

Varies per treatment strategy

Follow-up

Participants are monitored for quality of life improvements and cardiovascular hospitalizations

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Pace and Ablate
• Redo AF Ablation

Trial Overview The REDO-AF study compares two treatments: redoing the AF ablation or a new strategy called 'pace and ablate,' which involves pacing with AV node ablation. This small initial study of 16 people will help plan a bigger future trial.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

LBBP + AV Node ablation

Group II: Control Active Control 1 Intervention

Redo AF ablation

Who Is Running the Clinical Trial?

Jacqueline Joza

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10380427/

Outcomes of Atrioventricular Node Ablation and Pacing in ... Thirty-one deaths were recorded during an average 31-month follow-up period. The annual incidence of sudden death and sudden unexplained death was 1.9% and 1%, ...

2. ahajournals.org ahajournals.org/doi/10.1161/01.cir.101.10.1138

Clinical Outcomes After Ablation and Pacing Therapy for ... The calculated 1-year total and sudden death mortality rates after ablation and pacing therapy were 6.3% and 2.0%, respectively. Conclusions—Ablation and pacing ...

3. academic.oup.com academic.oup.com/eurheartj/article/45/46/4887/7821007

Atrioventricular node ablation for atrial fibrillation in the era of ... An irregular ventricular rhythm, independent of rate, was found to decrease the CO by 12%–15% when compared with a regular ventricular-paced ...

4. link.springer.com link.springer.com/article/10.1007/s10840-025-02038-3

Long-term outcomes of pace-and-ablate strategy in ... Outcomes of atrioventricular node ablation and pacing in patients with heart failure and atrial fibrillation: from cardiac resynchronization ...

5. revportcardiol.org revportcardiol.org/en-long-term-outcomes-after-radiofrequency-catheter-articulo-S2174204921000428

Long-term outcomes after radiofrequency catheter ablation ... In our study, despite pacemaker dependency, the clinical benefit of AV node ablation persisted in long-term follow-up, with reductions in hospitalizations and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12436554/

Long-term outcomes of pace-and-ablate strategy in ... The pace-and-ablate strategy is second -line therapy to obtain rate control in patients with persistent symptomatic atrial fibrillation (AF) ...

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(21)00621-4/fulltext

B-AB14-03 LEFT BUNDLE BRANCH PACING IN ATRIAL ... The success rate of permanent LBBP was higher than that of HBP (100% vs 81.5%, Figure 1). During LBBP, the acute threshold was 0.47±0.15V@0.5ms and the acute R- ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.122.010926

Propensity Score Matching With His Bundle Pacing LBBP is feasible, safe, and effective in patients with atrial fibrillation and HF post-AVJ ablation and has similar clinical benefits, a higher implant success ...