Pulsed Field Ablation for Atrial Fibrillation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new device system called the Volt™ PFA system for treating atrial fibrillation (AF), a heart condition that causes irregular and often rapid heartbeats. The trial targets individuals with AF symptoms that persist despite medication and who plan to undergo a catheter ablation procedure. Ideal candidates have documented episodes of paroxysmal (occasional) or persistent (lasting more than a week but less than a year) AF.
As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be refractory, intolerant, or contraindicated to at least one Class I-IV antiarrhythmic drug, which suggests that some medication changes might be necessary.
What prior data suggests that the Volt™ PFA system is safe for treating atrial fibrillation?
Research has shown that the Volt™ Pulsed Field Ablation (PFA) system is generally safe for treating atrial fibrillation (AF). In earlier studies, the system successfully isolated veins in the heart 99.2% of the time without causing serious side effects. Notably, no cases of phrenic nerve injury, a potential risk with heart procedures, occurred. Only 2.7% of patients experienced any safety-related issues, which is quite low. These results suggest that the Volt PFA system is well-tolerated and safe for patients.12345
Why are researchers excited about this trial?
The Volt PFA Catheter Sensor Enabled (SE) is unique because it uses pulsed field ablation (PFA) technology to treat atrial fibrillation. Unlike traditional treatments like radiofrequency ablation or cryoablation, which use heat or cold to destroy heart tissue causing irregular heartbeats, PFA uses electrical pulses to precisely target and disrupt problematic tissue without significant damage to surrounding areas. Researchers are excited about this treatment because it has the potential to offer a safer and more effective option with reduced risk of complications and shorter recovery times.
What evidence suggests that the Volt™ PFA system is effective for atrial fibrillation?
Research has shown that the Volt PFA system, which participants in this trial will receive, effectively treats atrial fibrillation, a type of irregular heartbeat. In earlier studies, 94.5% of patients did not require a second procedure. The system successfully isolated veins in 90% of cases, helping to stop irregular heartbeats. It is also safe, with only 2.7% of patients experiencing significant side effects. Long-term data indicates that the system remains effective and safe for up to 12 months. Overall, the Volt PFA system offers a promising option for managing both occasional and ongoing atrial fibrillation.13467
Who Is on the Research Team?
Sarah Kammer
Principal Investigator
Abbott
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 the index ablation procedure using the Volt™ PFA system
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Volt™ PFA system
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business