Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF

Persistent Atrial Fibrillation Clinical Trial

— PIVoTAL-IDE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04505163
• Other study ID #: PIVoTAL-IDE
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Dignity Health Medical Foundation
• 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone

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

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute & St. David's Medical Center	Austin	Texas
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	UCHealth Medical Center	Fort Collins	Colorado
United States	Nebraska Methodist Hospital-Methodist Physicians Clinic	Omaha	Nebraska
United States	Mercy General Hospital and Dignity Health Medical Foundation	Sacramento	California
United States	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Tampa Cardiac Specialists	Tampa	Florida
United States	MedStar Georgetown University Hospital and Medical Center	Washington	District of Columbia

Sponsors (12)

Lead Sponsor

Collaborator

Dignity Health Medical Foundation

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month freedom from recurrent atrial fibrillation	Number of participants with recurrent atrial fibrillation following catheter ablation	12 months
Secondary	All atrial arrhythmia recurrences	Number of atrial arrhythmia recurrences after the 90-day blanking period	During a follow-up period of 12 months
Secondary	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
Secondary	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
Secondary	Multiple procedure success	Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)	During a follow-up period of 12 months
Secondary	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
Secondary	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
Secondary	Freedom from repeat atrial fibrillation ablation	Repeat ablation for atrial fibrillation	During a follow-up period of 12 months
Secondary	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
Secondary	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
Secondary	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