Pulsed Field Ablation for Atrial Fibrillation

(OPTIMIZE Trial)

Recruiting at 36 trial locations

Overseen By Karin Froidcourt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Phosphodiesterase inhibitors

Disqualifiers: Atrial surgery, Heart failure, Hypertension, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies per procedure

699 Participants Needed

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 that does not improve with medication. The study aims to determine if PFA is safe and as effective as the current treatment method for this condition. Participants will be divided into two groups to compare the new treatment with the standard approach. Candidates may be suitable if they have experienced drug-resistant, persistent atrial fibrillation for more than a week but less than a year and are experiencing symptoms. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment approach.

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 must be willing to use systemic anticoagulation (blood thinners) during the study, and the use of phosphodiesterase inhibitors is not allowed within 24 hours of the procedure.

What prior data suggests that pulsed field ablation is safe for treating atrial fibrillation?

Research has shown that pulsed field ablation (PFA) is generally safe. In studies involving over 17,000 patients, PFA caused less unintended harm compared to other treatments. Another study found very few minor complications and no major problems with PFA in real-world use.

However, some risks remain. In one study, 2.3% of patients experienced issues like inflammation of the heart lining (pericarditis) or a heart attack (myocardial infarction), though these were uncommon.

Overall, most patients tolerate PFA well, and it is considered a safe option for treating atrial fibrillation. ^{1 2 3 4}

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 target heart tissue with greater precision. Unlike traditional thermal ablation methods like radiofrequency or cryoablation, PFA uses electrical pulses to selectively affect heart cells without damaging surrounding tissues. This approach could reduce complications and improve recovery times. Additionally, the integration of EGF mapping in the treatment arm allows for more targeted ablation, potentially increasing the effectiveness of the procedure. Overall, PFA represents a promising step forward in treating atrial fibrillation with enhanced safety and accuracy.

What evidence suggests that pulsed field ablation is effective for atrial fibrillation?

Research has shown that pulsed field ablation (PFA) is a promising treatment for persistent atrial fibrillation (AF), a heart rhythm issue. One study found that 63.5% of patients remained free of AF one year after the procedure, indicating that most did not experience AF again. Another study demonstrated that PFA successfully targeted problem areas in the heart in 99.7% of procedures. Additionally, 85.2% of patients reported significant improvements in heart-related symptoms and overall quality of life. This trial will compare two approaches: the Control Arm, involving PVI + PWA, and the Treatment Arm, involving PVI + EGF source(s) ablation. These findings suggest that PFA could be a viable option for individuals with AF who do not respond to medication. ^{4 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older, as required.

I have had atrial fibrillation for more than 7 days but less than a year.

My heart condition shows continuous irregular beats confirmed by tests.

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) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources or PFA of Pulmonary Veins and LA Posterior Wall

Varies per procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Extended Follow-up

Participants are monitored for long-term effectiveness and safety

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Field Ablation

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 3 Interventions

PVI + EGF source(s) ablation: The Treatment Arm, consisting of subjects undergoing PVI + EGF source(s) ablation. Adjunctive to PVI, the EGF-identified active sources above threshold will be ablated per protocol Section 10.8.11. If following PVI, a narrow channel that is approximately ≤ 1 cm is identified in the LAPW, ablation may be performed using the FARAPOINT Catheter.

Group II: Control Arm Active Control 2 Interventions

PVI + PWA: The Control Arm, consisting of subjects undergoing PVI + PWA. PWA will be performed adjunctive to PVI per protocol Section 10.8.10. Following confirmation of PWA, EGF mapping will be performed in the LA and RA, while Investigators, lab/nursing staff, and research personnel are blinded to the EGF maps.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

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

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. 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40306839/

Pulsed Field Ablation for Persistent Atrial Fibrillation Results: PFA in 339 patients (260 treatment and 79 roll-in) resulted in 99.7% success for both PVI and PWA. The primary safety endpoint was 2.3% ...

3. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02379-3/fulltext

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 ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013465

Long-Term Clinical Benefits of Pulsed Field Ablation in ... The minimal clinically important difference in QoL (≥5-point improvement in AFEQT) was achieved in 85.2% of patients. Patients who were free ...

5. nature.com nature.com/articles/s41591-024-03114-3

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 ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)01383-9/fulltext

PO-04-027 SAFETY OUTCOMES AND ... PFA for AF in a real-world setting showed a favorable safety profile with a minimal rate of non-severe complications, and no major adverse events. These ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.074485

Pulsed Field Ablation of Persistent Atrial Fibrillation With ... There are sparse high-quality safety and effectiveness data for pulsed field ablation (PFA) of persistent atrial fibrillation (PerAF), ...