Pulsed Field Ablation for Atrial Fibrillation
(DISRUPT-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies a new treatment option for people with atrial fibrillation (AF), a condition characterized by an irregular heartbeat. The trial aims to evaluate the effectiveness and safety of the Farapulse Pulsed Field Ablation System, a medical device used in heart ablation procedures. Participants will be divided into groups based on how their AF symptoms are monitored over time. This trial may suit individuals planning to undergo an ablation procedure specifically with the Farapulse system. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the Farapulse Pulsed Field Ablation System is safe for treating atrial fibrillation?
Research has shown that Farapulse PFA Technology is generally safe for treating atrial fibrillation (AF). In a large study involving 17,000 patients, less than 1% experienced complications during the procedure, indicating that serious issues were rare. Another study found that only 1.5% of patients encountered serious side effects within a year.
While the technology is considered safe, it carries some risks. For instance, there is a slightly higher chance of heart problems, such as a hole or tear in the heart or fluid buildup around the heart, compared to other methods. However, these risks remain quite low. Overall, most patients tolerate Farapulse PFA Technology well.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the Farapulse Pulsed Field Ablation (PFA) technology for atrial fibrillation (AF), which could offer a groundbreaking approach to treatment. Unlike traditional catheter ablation methods that use heat or extreme cold, the Farapulse PFA uses electric fields to target and eliminate abnormal heart tissue, potentially reducing damage to surrounding healthy tissue. This could lead to fewer complications and faster recovery times for patients. The trial's innovative monitoring strategies, including both symptomatic and asymptomatic checks, aim to provide a comprehensive understanding of the procedure's long-term safety and effectiveness.
What evidence suggests that the Farapulse PFA Technology is effective for treating atrial fibrillation?
Research has shown that Farapulse Pulsed Field Ablation (PFA) Technology effectively treats atrial fibrillation (AF), a common heart rhythm issue. In one study, about 80.8% of patients with occasional AF and 67.7% with more frequent AF were successfully treated after one year. Another study found that 63.5% of patients with persistent AF had a good outcome after one year. Farapulse PFA is known for fewer serious side effects compared to traditional treatments. It uses electrical fields to target and isolate problem areas in the heart, making it a promising option for AF patients. Participants in this trial will be assigned to different monitoring arms to evaluate the effectiveness and safety of Farapulse PFA Technology, with data collected at various intervals post-ablation.25678
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
Pre-procedure
Patient assessments occur at pre-procedure visits
Procedure
Ablation procedure using Farapulse Pulsed Field Ablation System
Post-procedure Monitoring
Monitoring for acute onset procedure or device-related complications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Farapulse PFA Technology
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Data will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit and 12-Months post-ablation (monitoring is triggered for symptomatic recurrences only). Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, and symptomatic recurrence.
Data will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit, interim continuous monitoring for asymptomatic arrhythmia recurrence at 6- and 12-Months post-ablation as well as monitoring as needed for symptomatic recurrences, and a 12-Month post-ablation office visit. Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, symptomatic recurrence as well as asymptomatic recurrence.
Data will be collected at pre-ablation/baseline and at time of the ablation procedure. Sites should follow the subjects per their standard of care and at a minimum report any acute onset procedure or device-related complications through 30-days post procedure. Data collection will include procedural workflow, procedural outcomes, and acute onset procedure or device-related complications through 30 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Heart Rhythm Clinical and Research Solutions, LLC
Lead Sponsor
Boston Scientific Corporation
Industry 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
one-year outcomes of the FARADISE registry | EP Europace
The study demonstrates high clinical effectiveness at 12-months: 80.8% in paroxysmal and 67.7% in non-paroxysmal atrial fibrillation (AF) ...
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 ...
FARAPULSE™ Pulsed Field Ablation (PFA) System
In a study of 17,000+ patients, FARAPULSE had zero reports of the serious adverse events seen in traditional thermal-based cardiac ablation—and an overall ...
Procedural performance and outcome after pulsed field ...
Pulsed field ablation (PFA) is a promising ablation technique for pulmonary vein isolation (PVI) with appealing advantages over radiofrequency (RF)
Pulsed Field Ablation of Persistent Atrial Fibrillation With ...
Using a total of 18±6 pulsed field applications, we achieved bidirectional CTI block in 139 of 141 patients (98.6%) with a transpired ablation ...
Safety of pulsed field ablation in more than 17000 patients ...
These trials demonstrated the feasibility and safety of PFA for AF ablation in a relatively small cohort of patients (<150) and few operators.
FARAPULSE™ Pulsed Field Ablation (PFA) System
In a real-world study of 17,000 patients, the FARAPULSE PFA procedure had a less than 1% rate of procedural complications.5. less than 2.1 percent. FARAPULSE is ...
Effectiveness and Safety of Pulsed Field Ablation in Patients ...
PFA shows noninferiority to thermal ablation in acute PVI, but has a higher risk of cardiac perforation or tamponade. It has lower recurrence ...
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