Cryoballoon Ablation for Persistent Atrial Fibrillation
(PIVoTAL-IDE Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.
Research Team
Arash Aryana, MD
Principal Investigator
Mercy General Hospital and Dignity Health Medical Foundation
Eligibility Criteria
This trial is for adults over 18 with persistent atrial fibrillation (AF) that lasts more than 7 days and hasn't improved with certain medications. Candidates should be undergoing their first catheter ablation, but prior treatment for a different heart rhythm issue is okay. People can't join if they have long-standing AF, reversible causes of AF, recent serious cardiovascular events, specific heart diseases or conditions, severe heart failure, a very large left atrium, blood clots in the heart, pregnancy or life expectancy less than one year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo catheter ablation for pulmonary vein isolation (PVI) and may receive additional posterior wall isolation (PWI) based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment, with clinic visits and heart event monitoring
Long-term monitoring
Participants' atrial fibrillation recurrence and other health metrics are tracked to assess long-term outcomes
Treatment Details
Interventions
- Cryoballoon PVI + Posterior Wall Isolation
- Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dignity Health Medical Foundation
Lead Sponsor
Sarasota Memorial Health Care System
Collaborator
Nebraska Methodist Hospital-Methodist Physicians Clinic
Collaborator
Mercy General Hospital and Dignity Health Medical Foundation
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
UC Health Medical Center
Collaborator
MedStar Georgetown University Hospital and Medical Center
Collaborator
Tampa Cardiac Specialists
Collaborator
Bethesda North Hospital
Collaborator
Brigham and Women's Hospital
Collaborator