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

Persistent Atrial Fibrillation Clinical Trial

— PIVoTAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057548
• Other study ID #: PIVotal-01
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2021
• Source: Sacramento EP Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 31, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Chronic
• Persistent Atrial Fibrillation

Intervention

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
• 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)

Locations

Country	Name	City	State
Japan	Heart Center, Japan Red Cross Yokohama-city Bay Hospital	Yokohama
United States	Mercy General Hospital and Dignity Health Heart and Vascular Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Arash Aryana, MD

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year freedom from recurrent atrial arrhythmias	Number of patients with recurrent atrial arrhythmias following catheter ablation	One year
Secondary	Overall complication rate	The type and frequency of complications following catheter ablation	During follow-up, assessed for an estimated total of one year.