Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation
ConditionAtrial Flutter Typical
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Catheter ablation
Treatment groups
620 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov