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NCT07649603

Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation

Sponsor: University of Rochester

View on ClinicalTrials.gov

Summary

Pulmonary vein isolation (PVI) via catheter ablation has been successfully employed for years to treat symptomatic atrial fibrillation (AF). Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in atrial flutter (AFL) patients. This is a multicenter single-blind randomized controlled trial, "Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation" (PREVENT AF II) to determine if PVI in conjunction with AFL ablation for patients with typical AFL results in a significant reduction in cardiac events and healthcare utilization.

Official title: Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation: The PREVENT-AF Study II

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2027-06

Completion Date

2032-05

Last Updated

2026-09-04

Healthy Volunteers

Conditions

Atrial Flutter Typical

Interventions

DEVICE

Catheter ablation

CTI ablation; pulmonary vein isolation (PVI)

Inclusion Criteria: 1. Age ≥ 55 years on date of consent 2. History of typical AFL and plans for a guideline-supported catheter ablation for AFL - including paroxysmal AFL defined as AFL with duration of up to 7 days and persistent AFL as longer than 7 days or if interrupted by cardioversion for clinical reasons and up to 1 year 3. No identifiable AF on any prior ECG within past 1 year 4. CHA2DS2 -VASc ≥ 2 Exclusion Criteria: 1. Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus) 2. AFL or AF due to reversible cause e.g. hyperthyroid state 3. Contraindication to systemic anticoagulation 4. Prior surgical or percutaneous cardiac ablation procedure any time in the past 5. Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past 6. LV ejection fraction \< 35% 7. Paroxysmal, persistent or longstanding persistent AF 8. Presence of NYHA Class IV congestive heart failure 9. Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date 10. Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent 11. Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures 12. Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date 13. Any medical condition likely to limit survival to \< 1 year 14. Renal failure requiring dialysis at time of consent 15. Pregnancy 16. History of non-compliance to medical therapy 17. Participation in other clinical trials (observational/lead registries are allowed) without approval from the DCC 18. Inability or unwillingness to provide informed consent 19. Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult 20. Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial