Pulsed Field Ablation vs Anti-Arrhythmic Drugs for Atrial Fibrillation
(AVANT GUARD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of two treatments for individuals with persistent atrial fibrillation, a type of irregular heartbeat. The goal is to determine whether pulsed field ablation, a new heart procedure, is safer and more effective than anti-arrhythmic drugs, which help control heart rhythm. It suits individuals who have experienced symptoms from persistent atrial fibrillation for more than a week but less than a year and have not recently used these heart medications. Participants must be willing to have a small heart monitor device placed under their skin for the study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but it does exclude those who have been treated with certain anti-arrhythmic drugs within 6 months before enrollment. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pulsed field ablation (PFA) is generally safe for treating atrial fibrillation, a type of irregular heartbeat. In one study with 339 patients, the procedure succeeded in almost all cases, with very few safety issues. Another study with 637 patients found a low rate of safety events, just 2%, indicating that serious problems are rare. Additionally, no major safety issues were reported within a week of the procedure in another group of patients.
Anti-arrhythmic drugs (AAD) are already used to treat irregular heartbeats like atrial fibrillation. Since these drugs are approved for this purpose, their safety is well understood. However, side effects can occur and vary depending on the specific drug.
Overall, both PFA and AAD treatments are generally well-tolerated by people with atrial fibrillation.12345Why are researchers excited about this trial?
Researchers are excited about Pulsed Field Ablation (PFA) for treating persistent atrial fibrillation because it offers a novel approach compared to traditional anti-arrhythmic drugs (AADs). Unlike AADs, which work by altering the electrical signals in the heart, PFA uses electrical fields to precisely target and eliminate problematic heart tissue without damaging surrounding areas. This technique could potentially reduce side effects and improve outcomes for patients. Additionally, PFA's precision and minimally invasive nature could lead to quicker recovery times and more effective management of atrial fibrillation.
What evidence suggests that this trial's treatments could be effective for persistent atrial fibrillation?
Research has shown that pulsed field ablation (PFA), one of the treatments studied in this trial, holds promise for treating ongoing atrial fibrillation (AF), a type of irregular heartbeat. One study found PFA effective for 63.5% of patients after one year, with nearly two-thirds experiencing significant benefits. Another study demonstrated that PFA reduced irregular heartbeats by 94%, greatly lessening symptoms for patients. These results suggest that PFA could be a strong first choice for treating persistent AF. Participants in this trial may receive either PFA or an Anti-Arrhythmic Drug (AAD) as their initial treatment.12346
Who Is on the Research Team?
Oussama Wazni, M.D.
Principal Investigator
The Cleveland Clinic
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
Randomization and Initial Treatment
Subjects are randomized to either Pulsed Field Ablation (PFA) or Anti-Arrhythmic Drug (AAD) therapy as initial treatment for persistent atrial fibrillation.
Blinding Period
Monitoring and adjustment of AAD dosage or PFA procedure to assess initial treatment efficacy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of atrial fibrillation burden and treatment success.
What Are the Treatments Tested in This Trial?
Interventions
- Flecainide, Sotalol, Propafenone, Dofetilide, Dronedarone
- Pulsed Field Ablation (PFA)
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