Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation

Starting soon · Not applicable

Conditions studied: Atrial Flutter Typical

In brief

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.

Key facts

Study ID

NCT07649603

Run by

University of Rochester

People needed

620

Starts

2027-06-01

Expected to finish

2032-05-01

Last updated by the study team

2026-06-16

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 55 years on date of consent
• 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
• Left atrial diameter ≥ 4.5 cm within 12 calendar months prior to or on consent date by transthoracic echocardiography
• No identifiable AF on any prior ECG within past 1 year
• CHA2DS2 -VASc ≥ 2

You may not qualify if…

• Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus)
• AFL or AF due to reversible cause e.g. hyperthyroid state
• Contraindication to systemic anticoagulation
• Prior surgical or percutaneous cardiac ablation procedure any time in the past
• Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past
• LV ejection fraction < 35%
• Paroxysmal, persistent or longstanding persistent AF
• Presence of NYHA Class IV congestive heart failure
• 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
• Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
• Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
• 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
• Any medical condition likely to limit survival to < 1 year
• Renal failure requiring dialysis at time of consent
• Pregnancy
• History of non-compliance to medical therapy
• Participation in other clinical trials (observational/lead registries are allowed) without approval from the DCC
• Inability or unwillingness to provide informed consent
• Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
• Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial

Full record on ClinicalTrials.gov

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