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PIVoTAL-IDE

Trial Overview

Official Title

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

Study Purpose

To compare cryoballoon ablation with posterior wall isolation to cryoballoon ablation in the treatment of persistent atrial fibrillation and the efficacy over a 12 month time span.

Diagnosis

Patients with persistent atrial fibrillation and a documented episode of a fib lasting more than 7 days within 1 year of procedure.

Eligibility

Patients with the following criteria are excluded

  • Recent stroke, TIA, heart attack, or unstable angina
  • Congenital heart disease
  • Pregnant Women
  • Previous left atrial ablation

Intervention

Cryoballoon Ablation with Posterior Wall Isolation versus Cryoballoon Ablation

For more information, visit ClinicalTrials.gov.

Key Participation Requirements
Trial Location(s)
Gender
All
Age
19 years and older
Enrollment Status
Active, Not Recruiting
Phase
Not Applicable
Methodist Health System Trial Code
NCT04505163