Clinical trial NCT04505163: Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
Official title: Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Catheter ablation
Cryoablation
Cryoballoon
Posterior left atrial wall ablation
Pulmonary vein isolation
Lead sponsor: Dignity Health Medical Foundation
Sponsor class: OTHER
Collaborators: name: Mercy General Hospital and Dignity Health Medical Foundation
name: Beth Israel Deaconess Medical Center
name: UC Health Medical Center
name: MedStar Georgetown University Hospital and Medical Center
name: Tampa Cardiac Specialists
name: Bethesda North Hospital
name: Brigham and Women's Hospital
name: Texas Cardiac Arrhythmia Institute At St. Davids Medical Center
name: St. Luke's Hospital and Health Network, Pennsylvania
name: Sarasota Memorial Health Care System
name: Nebraska Methodist Hospital-Methodist Physicians Clinic
First posted: 2020-08-10
Enrollment: 153
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 isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone.

The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.

Detailed description: Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI.

All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Consistent with the current definitions, all patients with Persistent AF must exhibit an episode of continuous AF that is sustained \>7 days.
* Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug
* 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 have documented episode of AF greater than 7 days in the year prior to the procedure

Exclusion Criteria:

* History of long-standing persistent AF
* 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 \<40%
* Congestive heart failure, class IV
* Left atrial (LA) diameter \>55 mm (parasternal long axis view)
* Patients with left atrial thrombus
* Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) 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: 12-month freedom from recurrent atrial fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: All atrial arrhythmia recurrences
timeFrame: During a follow-up period of 12 months
measure: Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)
timeFrame: During a follow-up period of 12 months
measure: Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)
timeFrame: During a follow-up period of 12 months
measure: Multiple procedure success
timeFrame: During a follow-up period of 12 months
measure: Relative reduction in atrial fibrillation burden
timeFrame: During a follow-up period of 12 months
measure: Freedom from cardioversion for recurrent atrial arrhythmias
timeFrame: During a follow-up period of 12 months
measure: Freedom from repeat atrial fibrillation ablation
timeFrame: During a follow-up period of 12 months
measure: Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence
timeFrame: During a follow-up period of 12 months
measure: Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence
timeFrame: During a follow-up period of 12 months
measure: New York Heart Association Functional Class as predictor of atrial fibrillation recurrence
timeFrame: During a follow-up period of 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy General Hospital and Dignity Health Medical Foundation
state: California
city: Fort Collins
country: United States
facility: UCHealth Medical Center
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital and Medical Center
state: District of Columbia
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Tampa
country: United States
facility: Tampa Cardiac Specialists
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Omaha
country: United States
facility: Nebraska Methodist Hospital-Methodist Physicians Clinic
state: Nebraska
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute & St. David's Medical Center
state: Texas
Study officials:
affiliation: Mercy General Hospital and Dignity Health Medical Foundation
name: Arash Aryana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aryana A, Pujara DK, Allen SL, Baker JH, Espinosa MA, Buch EF, Srivatsa U, Ellis E, Makati K, Kowalski M, Lee S, Tadros T, Baykaner T, Al-Ahmad A, d'Avila A, Di Biase L, Okishige K, Natale A. Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design. J Interv Card Electrophysiol. 2021 Oct;62(1):187-198. doi: 10.1007/s10840-020-00885-w. Epub 2020 Oct 3.