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

Last updated: October 19, 2025
Sponsor: Arash Aryana, MD
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Atrial Fibrillation

Cardiac Disease

Treatment

Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW

Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins

Clinical Study ID

NCT03057548
PIVotal-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females with an age >18 years undergoing a first-time catheter ablation ofAF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrialflutter) is permitted

  • All patients must understand the requirements of the study and be willing to complywith the post-study follow-up requirements

  • Patients must be in AF on the day of the procedure

Exclusion

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 ChorionicGonadotropin (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 orcompleting appropriate follow-up

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Phase:
Study Start date:
February 24, 2017
Estimated Completion Date:
May 31, 2020

Study 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.

Connect with a study center

  • Heart Center, Japan Red Cross Yokohama-city Bay Hospital

    Yokohama,
    Japan

    Site Not Available

  • Heart Center, Japan Red Cross Yokohama-city Bay Hospital

    Yokohama 1848354,
    Japan

    Site Not Available

  • Mercy General Hospital and Dignity Health Heart and Vascular Institute

    Sacramento, California 95819
    United States

    Site Not Available

  • Mercy General Hospital and Dignity Health Heart and Vascular Institute

    Sacramento 5389489, California 5332921 95819
    United States

    Site Not Available

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