NCT04505163

Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Dignity Health Medical Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI. All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Standard Cryoballoon Pulmonary Vein Isolation (PVI)	Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
DEVICE	Cryoballoon PVI + Posterior Wall Isolation	Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component

Timeline

• Start date: 2021-04-30
• Primary completion: 2024-04-30
• Completion: 2024-12-31
• First posted: 2020-08-10
• Last updated: 2023-09-06

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study