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

• ClinicalTrials.gov Identifier: NCT03057548
• Recruitment Status: Active, not recruiting
• First Posted: February 20, 2017
• Last Update Posted: May 19, 2020
• Sponsor: Arash Aryana, MD
• Information provided by (Responsible Party): Arash Aryana, MD, Sacramento EP Research

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation Chronic; Persistent Atrial Fibrillation	Procedure: Cryo or RF Ablation only of Pulmonary Veins; Procedure: Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation for Treatment of Persistent Atrial Fibrillation (PIVoTAL) Trial
• Actual Study Start Date: February 24, 2017
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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 RF Ablation only of Pulmonary Veins; Artic Front Advance Cardiac Cryoabltion 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

Outcome Measures

Primary Outcome Measures :

1. 1-year freedom from recurrent atrial arrhythmias [ Time Frame: One year ]
   Number of patients with recurrent atrial arrhythmias following catheter ablation

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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-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

Contacts and Locations

Locations

United States, California

Mercy General Hospital and Dignity Health Heart and Vascular Institute

Sacramento, California, United States, 95819

Japan

Heart Center, Japan Red Cross Yokohama-city Bay Hospital

Yokohama, Japan

Sponsors and Collaborators

Arash Aryana, MD

Investigators

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

More Information

• Responsible Party: Arash Aryana, MD, Cardiac Electrophysiologist / Principal Investigator, Sacramento EP Research
• ClinicalTrials.gov Identifier: NCT03057548
• Other Study ID Numbers: PIVotal-01
• First Posted: February 20, 2017
• Last Update Posted: May 19, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arash Aryana, MD, Sacramento EP Research:

Atrial Fibrillation; Long-Standing Atrial Fibrillation; Posterior Left Atrial Wall Ablation

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes