Clinical trial NCT03057548: Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
Official title: Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation for Treatment of Persistent Atrial Fibrillation (PIVoTAL) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation Chronic
Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Long-Standing Atrial Fibrillation
Posterior Left Atrial Wall Ablation
Lead sponsor: Sacramento EP Research
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 1-year freedom from recurrent atrial arrhythmias
timeFrame: One year
Secondary outcomes:
measure: Overall complication rate
timeFrame: During follow-up, assessed for an estimated total of one year.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy General Hospital and Dignity Health Heart and Vascular Institute
state: California
city: Yokohama
country: Japan
facility: Heart Center, Japan Red Cross Yokohama-city Bay Hospital
Study officials:
affiliation: Mercy General Hospital and Dignity Health Heart and Vascular Institute
name: Arash Aryana, MD
role: PRINCIPAL_INVESTIGATOR
References: