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

Not Applicable

Completed

• Conditions: Atrial Fibrillation Chronic; Persistent Atrial Fibrillation
• Interventions: Procedure: Cryo or RF Ablation only of Pulmonary Veins; Procedure: Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW

• Registration Number: NCT03057548
• Lead Sponsor: Arash Aryana, MD

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.

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 Timeline

• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Study Start: 2017-02-24
• Primary Completion: 2020-05-13
• Study Completion: 2020-05-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Vein Isolation (PVI)	Cryo or RF Ablation only of Pulmonary Veins	Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone.
PVI & Posterior Left Atrial Ablation	Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW	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)

Primary Outcome Measures

Name	Time	Method
1-year freedom from recurrent atrial arrhythmias	One year	Number of patients with recurrent atrial arrhythmias following catheter ablation

Secondary Outcome Measures

Name	Time	Method
Overall complication rate	During follow-up, assessed for an estimated total of one year.	The type and frequency of complications following catheter ablation

Trial Locations

Locations (2)

Heart Center, Japan Red Cross Yokohama-city Bay Hospital; 🇯🇵 Yokohama, Japan

Mercy General Hospital and Dignity Health Heart and Vascular Institute; 🇺🇸 Sacramento, California, United States