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

October 19, 2025 updated by: Arash Aryana, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Yokohama, Japan
        • Heart Center, Japan Red Cross Yokohama-city Bay Hospital
  • United States
    • California
      • Sacramento, California, United States, 95819
        • Mercy General Hospital and Dignity Health Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
  • Patients must be in AF on the day of the procedure

Exclusion Criteria:

  • Any reversible cause of AF (post-operative, thyroid disorder, etc)
  • Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
  • Patients with any corrected or uncorrected congenital heart disease
  • Patients with a history of hypertrophic cardiomyopathy
  • Patients with cardiomyopathy and a left ventricular ejection fraction <35%
  • Congestive heart failure, class IV
  • Women who are known to be pregnant or have had a positive β-Human Chorionic Gonadotropin (β-HCG) test 7 days prior to procedure
  • Patients whose life expectancy is <1 year
  • History of left-sided left atrial ablation (catheter or surgically-based)
  • Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulmonary Vein Isolation (PVI)

Cryoablation only of Pulmonary Veins

or

Radiofrequency ablation only of Pulmonary Veins

Pulmonary Vein Isolation (PVI) alone.
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

Other Names:
  • Artic Front Advance Cardiac Cryoablation System
  • FDA Approved Radiofrequency Ablation Catheter
Experimental: PVI & Posterior Left Atrial Ablation

Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall

or

Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall

PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW)
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)

Other Names:
  • Cryoablation of Pulmonary Veins plus RF Ablation of PLAW
  • RF Ablation of Pulmonary Veins plus RF Ablation of PLAW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Freedom From Recurrent Atrial Arrhythmias
Time Frame: One year
The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Complication Rate
Time Frame: During follow-up, assessed for an estimated total of one year.
The type and frequency of complications following catheter ablation
During follow-up, assessed for an estimated total of one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arash Aryana, MD

Investigators

  • Principal Investigator: Arash Aryana, MD, Mercy General Hospital and Dignity Health Heart and Vascular Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2017

Primary Completion (Actual)

May 13, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

October 19, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIVotal-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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