Pulsed Field Ablation for Atrial Fibrillation
(OPTIMIZE Trial)
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.1234Why 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.4567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Participants are monitored for long-term effectiveness and safety
What Are the Treatments Tested in This Trial?
Interventions
- Pulsed Field Ablation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
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
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 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% ...
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 ...
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 ...
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 ...
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 ...
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), ...
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