Ablation Techniques for Atrial Fibrillation

(REPEAT-AF Trial)

Overseen By Becky Horn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Heart failure, Coronary disease, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve treatment for atrial fibrillation, a common irregular heartbeat. It compares two methods: the standard ablation procedure, known as Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI), and a new approach that includes treating an extra area of the heart, called Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI). The goal is to determine if the new method improves symptoms and overall well-being. Suitable candidates are adults who underwent ablation for atrial fibrillation more than three months ago and still experience symptoms. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these ablation techniques are safe for atrial fibrillation?

A previous study found that patients who received an additional step called left atrial posterior wall isolation (PWI) alongside the standard procedure for treating atrial fibrillation (AF), known as pulmonary vein isolation (PVI), experienced similar safety outcomes to those who underwent only the standard PVI. Specifically, the rate of adverse events was 3.8% for PVI alone and 1.9% for PVI with PWI, which was not a significant difference. Both procedures were generally well-tolerated.

Research has also shown that PWI can be safely performed in many cases, with good results in reducing irregular heart rhythms over a year. Overall, adding PWI to PVI does not appear to increase safety concerns compared to PVI alone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these ablation techniques for atrial fibrillation because they aim to improve the precision and effectiveness of existing procedures. Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) might offer better control over irregular heartbeats by targeting additional areas of the heart, potentially reducing the recurrence of atrial fibrillation. Meanwhile, PVI without PWI focuses on isolating the pulmonary veins, a standard practice, but the trial aims to compare their outcomes directly. This approach can help determine if adding PWI provides significant benefits, ultimately guiding more personalized and effective treatment strategies for patients.

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

This trial will compare two ablation techniques for atrial fibrillation: Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) and PVI without PWI. Research has shown mixed results when adding PWI to PVI for treating irregular heartbeats. Some studies found that PWI does not significantly reduce the recurrence of these irregular heartbeats compared to PVI alone. For example, one study found that PWI did not help patients with ongoing atrial fibrillation (AF) remain free from these irregular heartbeats. However, other studies suggest that combining PWI with PVI can reduce the recurrence of AF in persistent cases. Pulmonary Vein Isolation alone is often used but works differently for ongoing AF compared to occasional AF. Overall, the evidence is mixed, showing both potential benefits and limitations. ^{2 5 6 7 8}

Who Is on the Research Team?

Johnathan Steinberg, MD

Principal Investigator

University of Rochester

Wojciech Zareba, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for people who've had one ablation procedure for persistent atrial fibrillation (AF) but still experience irregular heartbeats. They must be eligible and willing to undergo another ablation, follow post-procedure instructions, and sign a consent form.

Inclusion Criteria

Willingness to comply with all post-procedural follow-up requirements and to sign informed consent

I am 18 years old or older.

I had a PVI ablation for AF more than 3 months ago.

Exclusion Criteria

Prior valve replacement with mechanical prosthesis

Any medical condition likely to limit survival to < 1 year

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo repeat ablation procedures, with or without additional treatment of the left atrial posterior wall

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of atrial fibrillation burden and major clinical events

48 months

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
• Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)

Trial Overview The study compares two heart ablation techniques in AF patients: one includes treating the left atrial posterior wall along with pulmonary vein isolation (PVI), while the other involves only PVI without additional treatment.

How Is the Trial Designed?

Group I: Repeat PVI without LA PWI Experimental Treatment 1 Intervention

Group II: Repeat PVI with LA PWI Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34911157/

Outcomes of posterior wall isolation with pulmonary vein ... This study sought to evaluate the efficacy of PWI in addition to pulmonary vein isolation (PVI) in patients presenting with pAF and normal left atrial voltage.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2800186

Effect of Catheter Ablation Using Pulmonary Vein Isolation ... Among patients with persistent AF undergoing first-time catheter ablation, the addition of PWI to PVI did not improve freedom from atrial arrhythmias compared ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527325000300

Posterior left atrial wall isolation for treatment of persistent ... According to our updated meta-analysis, the addition of PWI to PVI was not associated with a reduction of atrial arrhythmia recurrences. A ...

4. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4139264

Abstract 4139264: Outcomes Of Pulmonary Vein Isolation ... The left atrial posterior wall has been recognized as a significant anatomical area involved in the onset and persistence of atrial fibrillation ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31805423/

Safety and efficacy outcomes of left atrial posterior wall ... Results: Among 558 patients who underwent ablation for persistent AF, 78 (14%) underwent PVI + PWI, 255 (46%) underwent PVI, and 225 (40%) underwent PVI + ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.118.007005

Feasibility, Safety, and Efficacy of Posterior Wall Isolation ... PWI as an end point of AF ablation can be achieved in a large proportion of cases with good rates of 12-month freedom from atrial arrhythmia.

8. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(24)00180-1/fulltext

The role of left atrium posterior wall isolation in patients ... Pulmonary vein isolation (PVI) + posterior wall isolation (PWI) significantly increase atrial tachyarrhythmia-free survival compared to PVI alone.