Pulsed-Field Ablation for Atrial Fibrillation

(PEAK-AF Trial)

Not currently recruiting at 9 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Xu Liu
Must be taking: Class I/III antiarrhythmics
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called pulsed-field ablation (PFA) for individuals with persistent atrial fibrillation, a type of irregular heartbeat lasting more than a week. Researchers compare two approaches: one uses PFA to target specific heart areas identified by special mapping, and the other does not. The goal is to determine which method is more effective and safe in stopping the irregular beats. Individuals who have experienced atrial fibrillation for over a week and find medications ineffective might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should have drug-resistant atrial fibrillation, which suggests that you might continue your current medications if they are not effective. It's best to discuss this with the trial coordinators.

What prior data suggests that this pulsed-field ablation technique is safe for atrial fibrillation?

Research has shown that pulsed-field ablation (PFA) is generally safe for treating atrial fibrillation (AF). In a study involving over 17,000 patients, PFA avoided many complications associated with other methods, making it a safer choice. Another study confirmed PFA's effectiveness and low complication rates, even in patients over 75 years old. Importantly, PFA does not cause severe issues like atrioesophageal fistula, a serious problem that can occur with other treatments.

The safety of PFA remains consistent across different patient groups. For instance, studies have shown that both men and women experience similar safety outcomes with PFA. Additionally, patients with heart failure tolerate PFA well, with a higher likelihood of remaining free from irregular heart rhythms after treatment. Overall, early findings suggest that PFA is a promising and well-tolerated treatment option for atrial fibrillation.12345

Why are researchers excited about this trial?

Researchers are excited about pulsed-field ablation (PFA) for atrial fibrillation because it offers a unique way to treat the heart's erratic rhythms. Unlike standard treatments like radiofrequency or cryoablation that use heat or extreme cold, PFA uses electrical pulses to precisely target and isolate problematic heart tissues. This method aims to reduce tissue damage and improve recovery times. Additionally, the use of electrogram mapping in one of the trial's approaches helps tailor the procedure to the individual patient's heart, potentially increasing its effectiveness.

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

Research has shown that pulsed-field ablation (PFA) offers a promising treatment for atrial fibrillation (AF), a condition characterized by an irregular heartbeat. Studies have found PFA to be effective, with approximately 63.5% of patients experiencing success one year after the procedure. This method generally matches the effectiveness of other established treatments and tends to be safer, with a lower risk of damaging nearby tissues. PFA isolates areas in the heart that cause irregular rhythms, particularly around the pulmonary veins. In this trial, participants in one arm will undergo PFA-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI) with adjunctive ablation guided by electrogram mapping, potentially improving heart rhythm outcomes by targeting specific heart regions. Participants in another arm will receive PFA-based PVI and PWI without adjunctive ablation guided by electrogram mapping.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 80 with persistent atrial fibrillation that hasn't improved with at least one antiarrhythmic drug. Participants must have had AF lasting over 7 days, confirmed by ECG and a recent Holter monitor, and be willing to follow study procedures.

Inclusion Criteria

I am 18-79, have persistent AF not controlled by medication, and can join all study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), with or without adjunctive ablation guided by Electrogram Mapping of Key Substrates

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 36 months

36 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Electrogram Mapping
  • Pulsed-Field Ablation

Trial Overview

The study compares two treatments for persistent atrial fibrillation: pulsed-field ablation (PFA) targeting standard heart areas alone versus PFA plus extra treatment guided by detailed electrical mapping. Patients are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: EGMExperimental Treatment1 Intervention
Group II: PWIActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xu Liu

Lead Sponsor

Trials
4
Recruited
720+

Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine

Collaborator

Citations

Outcomes With Pulsed Field Ablation Versus Conventional ...

Among patients with paroxysmal AF undergoing catheter ablation, PFA is associated with favorable outcomes, including lower recurrence and ...

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 ...

Long-Term Clinical Benefits of Pulsed Field Ablation in ...

Pulsed field ablation (PFA) has demonstrated promising safety and effectiveness that is generally equivalent to or better than established ...

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 ...

Pulsed field ablation was not superior to radiofrequency ...

The primary endpoint, single-procedure success at 12 months, was high and similar between the procedure types: 77.2% in the PFA group and 77.6% ...

Safety and Efficacy of Pulsed Field Ablation for Atrial ... - PMC

PFA in patients > 75 years is associated with low complication rates and favorable rhythm outcomes, comparable to those in younger patients.

Safety of pulsed field ablation in more than 17000 patients ...

Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with ...

Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation

ADMIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure.

Studies Spotlight Safety Concerns With Pulsed-Field ...

PFA avoids catastrophic complications like atrioesophageal fistula, which carries a 50% mortality rate and a high rate of permanent disability.

Safety and Effectiveness of Pulsed Field Ablation for Atrial ...

PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF.