Back to results

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

Primary Purpose

Persistent Atrial Fibrillation

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Cryoballoon PVI + Posterior Wall Isolation

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial fibrillation, Catheter ablation, Cryoablation, Cryoballoon, Posterior left atrial wall ablation, Pulmonary vein isolation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Cryoballoon PVI + Posterior Wall Isolation

Arm Description

Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Outcomes

Primary Outcome Measures

12-month freedom from recurrent atrial fibrillation

Number of participants with recurrent atrial fibrillation following catheter ablation

Secondary Outcome Measures

All atrial arrhythmia recurrences

Number of atrial arrhythmia recurrences after the 90-day blanking period

Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)

Change in CCS-SAF from baseline to 12 months

Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)

Change in AFEQT from baseline to 12 months

Multiple procedure success

Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)

Relative reduction in atrial fibrillation burden

Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation

Freedom from cardioversion for recurrent atrial arrhythmias

Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required

Freedom from repeat atrial fibrillation ablation

Repeat ablation for atrial fibrillation

Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence

Change in left atrial diameter (in millimeters) following ablation

Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence

Change in left atrial ejection fraction (in percentage) following ablation

New York Heart Association Functional Class as predictor of atrial fibrillation recurrence

Change in New York Heart Association Functional Class following ablation

Full Information

NCT ID

NCT04505163

First Posted

July 10, 2020

Last Updated

September 1, 2023

Sponsor

Dignity Health Medical Foundation

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04505163

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 30, 2021 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dignity Health Medical Foundation

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation, Catheter ablation, Cryoablation, Cryoballoon, Posterior left atrial wall ablation, Pulmonary vein isolation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Arm Type

Active Comparator

Arm Description

Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Arm Title

Cryoballoon PVI + Posterior Wall Isolation

Arm Type

Experimental

Arm Description

Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Intervention Type

Procedure

Intervention Name(s)

Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Other Intervention Name(s)

Arctic Front Advance Cardiac Cryoablation System

Intervention Description

Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone

Intervention Type

Device

Intervention Name(s)

Cryoballoon PVI + Posterior Wall Isolation

Other Intervention Name(s)

Arctic Front Advance Cardiac Cryoablation System

Intervention Description

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

Primary Outcome Measure Information:

Title

12-month freedom from recurrent atrial fibrillation

Description

Number of participants with recurrent atrial fibrillation following catheter ablation

Time Frame

12 months

Secondary Outcome Measure Information:

Title

All atrial arrhythmia recurrences

Description

Number of atrial arrhythmia recurrences after the 90-day blanking period

Time Frame