Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF (PIVoTAL-IDE)

Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI); Device: Cryoballoon PVI + Posterior Wall Isolation

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arash Aryana, MD; Phone Number: 916-453-2684; Email: arash.aryana@dignityhealth.org
• Study Contact Backup: Name: Shelley Allen, RN; Phone Number: 916-453-2626; Email: shelley.allen@dignityhealth.org

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Mercy General Hospital and Dignity Health Medical Foundation
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • UCHealth Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital and Medical Center
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Health Care System
    • Tampa, Florida, United States, 33558
      • Tampa Cardiac Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital-Methodist Physicians Clinic
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Institute & St. David's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Cryoballoon Pulmonary Vein Isolation (PVI); Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters	Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI); Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone; Other Names: Arctic Front Advance Cardiac Cryoablation System
Experimental: Cryoballoon PVI + Posterior Wall Isolation; Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters	Device: Cryoballoon PVI + Posterior Wall Isolation; Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component; Other Names: Arctic Front Advance Cardiac Cryoablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month freedom from recurrent atrial fibrillation	Number of participants with recurrent atrial fibrillation following catheter ablation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All atrial arrhythmia recurrences	Number of atrial arrhythmia recurrences after the 90-day blanking period	During a follow-up period of 12 months
Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)	Change in CCS-SAF from baseline to 12 months	During a follow-up period of 12 months
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)	Change in AFEQT from baseline to 12 months	During a follow-up period of 12 months
Multiple procedure success	Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)	During a follow-up period of 12 months
Relative reduction in atrial fibrillation burden	Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation	During a follow-up period of 12 months
Freedom from cardioversion for recurrent atrial arrhythmias	Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required	During a follow-up period of 12 months
Freedom from repeat atrial fibrillation ablation	Repeat ablation for atrial fibrillation	During a follow-up period of 12 months
Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence	Change in left atrial diameter (in millimeters) following ablation	During a follow-up period of 12 months
Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence	Change in left atrial ejection fraction (in percentage) following ablation	During a follow-up period of 12 months
New York Heart Association Functional Class as predictor of atrial fibrillation recurrence	Change in New York Heart Association Functional Class following ablation	During a follow-up period of 12 months

Collaborators and Investigators

• Sponsor: Dignity Health Medical Foundation
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; St. Luke's Hospital and Health Network, Pennsylvania; Mercy General Hospital and Dignity Health Medical Foundation; UC Health Medical Center; MedStar Georgetown University Hospital and Medical Center; Tampa Cardiac Specialists; Bethesda North Hospital; Texas Cardiac Arrhythmia Institute At St. Davids Medical Center; Sarasota Memorial Health Care System; Nebraska Methodist Hospital-Methodist Physicians Clinic
• Investigators: Principal Investigator: Arash Aryana, MD, Mercy General Hospital and Dignity Health Medical Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Catheter ablation; Cryoablation; Pulmonary vein isolation; Cryoballoon; Posterior left atrial wall ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PIVoTAL-IDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes