NCT03057548

Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)

Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation for Treatment of Persistent Atrial Fibrillation (PIVoTAL) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Arash Aryana, MD · 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 ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone. The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.

Detailed description

Patients with persistent or long-standing persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. All patients are required to be in atrial fibrillation (AF) on the day of the ablation procedure. After ablation (isolation) of the pulmonary veins (PVI) is complete, and while still in the electrophysiology lab, all patients are randomized to either PVI, alone \[Group 1\] or the combination of PVI plus ablation of the posterior left atrial wall (PLAW) \[Group 2\]. For those patients randomized to PVI, their ablation procedure is complete at this time. For those patients randomized to PVI plus PLAW, they will have the additional ablation to the posterior left atrial wall performed. All study patients have the same follow-up after their ablation procedure: clinic visits at 3, 6, and 13 months; a heart event monitor is worn for 7-14 days before these visits. An echocardiogram is done at 4-6 months after the ablation procedure. Blood thinners are usually recommended for three months after the ablation procedure and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the judgement of their study doctor. Information about patient's medical history, heart arrhythmias, and atrial fibrillation will be collected during the study. This information will be analyzed as part of the study.

Conditions

• Atrial Fibrillation Chronic
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins	Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins OR FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins. Ablation of the Pulmonary Veins alone
PROCEDURE	Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW	Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW OR RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)

Timeline

• Start date: 2017-02-24
• Primary completion: 2020-05-13
• Completion: 2020-05-31
• First posted: 2017-02-20
• Last updated: 2025-11-05
• Results posted: 2025-11-05

Locations

2 sites across 2 countries: United States, Japan