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

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Fibrillation Chronic, Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Cryo or RF Ablation only of Pulmonary Veins
* Procedure: Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary Vein Isolation (PVI)<br>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<br>* 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<br>* Other names: FDA Approved Radiofrequency Ablation Catheter;|
| Experimental: PVI & Posterior Left Atrial Ablation<br>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<br>* 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)<br>* Other names: 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 | Number of patients with recurrent atrial arrhythmias following catheter ablation | One year | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Long-Standing Atrial Fibrillation, Posterior Left Atrial Wall Ablation