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Research & Innovation

PIVoTAL-IDE Trial

Clinical Trials

PIVoTAL-IDE Trial

Left Atrial Posterior Wall Isolation in Conjunction with Pulmonary Vein Isolation Using the Cryoballon for Treatment of Persistent Atrial FibrilLation Trial (PIVoTAL-IDE Trial)

Physician & Study Coordinator
Synopsis

Synopsis: 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.

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Eligibility Criteria

Inclusion Criteria

  • Consistent with the current definitions, all patients with AFp must exhibit an episode of continuous AF that is sustained >7 days.
  • Patients must have symptomatic AFp refractory or intolerant to at least one class I, II, III or IV antiarrhythmic drug
  • Males and females with an age <18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted

Exclusion Criteria

  • Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
  • Patients with a history of hypertrophic cardiomyopathy
  • Patients with cardiomyopathy and a left ventricular ejection fraction <40%
  • Congestive heart failure, class IV
  • Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
  • History of left-sided left atrial ablation (catheter or surgically-based)

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