50 Participants NeededMy employer runs this trial

Remapping Procedure for Atrial Fibrillation

(PRECLUDE Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
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 examines the effectiveness of pulsed field ablation (PFA) for individuals with atrial fibrillation who also require a device to block a part of the heart. The researchers aim to determine if the initial treatment remains effective or if additional treatment is necessary. This trial suits individuals with atrial fibrillation symptoms seeking a non-drug option for clot prevention. Participants should not have undergone previous treatments like ablation or certain heart procedures. As an unphased trial, it offers participants the chance to contribute to groundbreaking research in non-drug treatment options for atrial fibrillation.

Will I have to stop taking my current medications?

The trial information does not specify if 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 this remapping procedure is safe for atrial fibrillation patients?

Research has shown that the remapping procedure, which includes pulsed field ablation (PFA), is generally safe for treating atrial fibrillation. One study found no major harmful effects directly linked to the device or procedure. Another study reported that only 3.0% of participants experienced significant side effects, indicating that very few people had problems. A different report showed a very low major complication rate of just 1.25%. These findings suggest that most patients handle the treatment well.12345

Why are researchers excited about this trial?

Unlike the standard treatments for atrial fibrillation, which often involve medication or catheter ablation alone, the remapping procedure combines a novel approach with a Left Atrial Appendage Occlusion (LAAO) implant and potentially additional ablation. Researchers are excited about this method because it offers a more comprehensive approach to managing atrial fibrillation by not only targeting the irregular heart rhythms but also addressing the risk of stroke with the LAAO implant. This dual-action approach could lead to better long-term outcomes for patients by reducing both symptoms and complications associated with atrial fibrillation.

What evidence suggests that this remapping procedure is effective for atrial fibrillation?

Research has shown that the technique used in pulsed field ablation (PFA) for treating atrial fibrillation yields promising results. One study found that 93.5% of the treated areas in the heart remained isolated, a key indicator of success. Other studies have reported success rates of 50-70% for similar procedures. These findings suggest that PFA effectively helps many patients maintain a regular heart rhythm. This procedure is considered a safe and effective method for managing atrial fibrillation.678910

Are You a Good Fit for This Trial?

This trial is for people with atrial fibrillation who have already had a pulsed field ablation and are now scheduled to get a left atrial appendage occlusion device. Participants should be able to undergo both procedures safely.

Inclusion Criteria

Participant has a CHADSVASc≥3
I am willing and able to give my consent to join the study.
I have symptoms from atrial fibrillation or have heart failure or weak heart function.
See 4 more

Exclusion Criteria

I have a mass or blood clot inside my heart.
Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
I am unable to follow up as an outpatient or understand the risks and benefits of procedures.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Ablation Procedure

Participants undergo pulsed field ablation (PFA) as part of the standard of care for atrial fibrillation treatment

1 day
1 visit (in-person)

Remapping and LAAO Implantation

Remapping procedure with LAAO implant, with or without additional ablation, to assess the durability of the initial PFA

1 day
1 visit (in-person)

Follow-up

Participants are monitored for arrhythmia recurrence and clinical outcomes, including extended Holter monitoring at 6 and 12 months post-remapping

12 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Remapping Procedure

Trial Overview

The study looks at how well the initial heart ablation worked by checking during the procedure to insert an LAAO device. If needed, more ablation may be done at that time. There is no comparison group; all participants receive this approach.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single-arm, open label - all enrolled subjectsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Boston Scientific Corporation

Industry Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1-Year outcomes of the first-in-human PULSE-EU trial

Remapping (43/48 patients [89.5%]) revealed that 158 of 169 PVs (93.5%) were durably isolated. The only complication was a drug-responsive ...

Atrial Fibrillation (AF) Catheter Ablation Success Rates

For multiple procedures, the majority reported success rates of 70% or more for paroxysmal atrial fibrillation and 50% or more for persistent atrial ...

Very Long-Term Results Of Atrial Fibrillation Ablation Confirm ...

Published data in the literature suggest that success rates following ablation of AF are relatively favorable (50-70%)[3,4,5] but most studies have reported ...

Remapping Atrial Fibrillation Treatment | DAIC

vMap converts ECG data into 2D and 3D arrhythmia source maps using data leveraged from millions of arrhythmia simulations.

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 ...

One-year outcomes of a conformable single-shot pulsed ...

Herein, we report the full long-term results of treating PAF with this single-shot PFA catheter, including efficiency, safety, chronic efficacy, ...

AF ablation using a novel “single-shot” map-and ...

Safety outcomes As shown in. On invasive remapping, the rate of durable PVI was 93.5% of PVs. There were no device- or procedure-related major adverse events.

Heart Rhythm 2025 Showcases New Advancements in ...

The results showed 100% acute PVI with durable isolation in 84.5% of pulmonary veins at 3-month remapping and a 3.0% primary adverse event rate,

Long-term results of ablation index guided atrial fibrillation ...

It is safe with a low major complication rate of 1.25%. Age >75 years, BMI >35 kg/m2, and markedly enlarged atria were associated with higher recurrence rates.

2024 European Heart Rhythm Association ...

Several studies, including RCTs, have demonstrated that concomitant AF surgery is safe and does not increase operative mortality.1313,1314,1327 ...