STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation

NCT ID: NCT03118518

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-23
• Study Completion Date: 2020-06-25

Brief Summary

To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.

Detailed Description

Subjects with paroxysmal atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.

Conditions

Atrial Fibrillation; Atrial Fibrillation New Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-arrhythmic drug

Group Type: ACTIVE_COMPARATOR

Antiarrhythmic drug

Intervention Type: DRUG

Antiarrhythmic drug initiation

Cryoablation

Group Type: EXPERIMENTAL

Cryoablation

Intervention Type: DEVICE

Pulmonary vein isolation via ablation with cryoballoon catheter

Interventions

Cryoablation

Pulmonary vein isolation via ablation with cryoballoon catheter

Intervention Type: DEVICE

Antiarrhythmic drug

Antiarrhythmic drug initiation

Intervention Type: DRUG

Other Intervention Names

ArcticFront Advance Cardiac CryoAblation Catheter

Eligibility Criteria

Inclusion Criteria

• A diagnosis of symptomatic paroxysmal AF with the following documentation: (1) physician's note indicating recurrent self- terminating AF or paroxysmal AF; and (2) any ECG documented AF within 6 months prior to enrollment.
• Age 18-80

Exclusion Criteria

• History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
• Prior persistent AF (cardioversion after 48 hours or continuous AF that is sustained >7 days)
• Left atrial diameter greater than 5.0 cm
• Prior left atrial ablation or left atrial surgical procedure
• Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Body mass index (BMI) >35 kg/m2
• Presence of any pulmonary vein stents
• Known presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Presence of any cardiac valve prosthesis
• Moderate or severe mitral valve regurgitation or stenosis
• Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/ percutaneous transluminal coronary angioplasty or coronary artery stenting which occurred during the 90 day interval preceding the date the subject signed the Informed Consent Form
• Unstable angina
• New York Heart Association (NYHA) class III or IV congestive heart failure and/or known left ventricular ejection fraction (LVEF) less than 45%
• Diagnosis of primary pulmonary hypertension
• Rheumatic heart disease
• Thrombocytosis, thrombocytopenia
• Contraindication to anticoagulation therapy
• Active systemic infection
• Hypertrophic cardiomyopathy
• Cryoglobulinemia
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, obstructive sleep apnea, and acute alcohol toxicity.
• Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 180 day interval preceding the date the subject signed the Informed Consent Form, or any known unresolved complications from previous stroke/transient ischemic attack
• Existing thrombus
• Pregnancy
• Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed.
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
• Patients with contraindications to a Holter monitor
• Unwilling or unable to comply fully with study procedures and follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oussama Wazni, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Gopi Dandamudi, MD

Role: PRINCIPAL_INVESTIGATOR

Franciscan Heart & Vascular Associates at St. Joseph

Steve Nissen, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Grandview Medical Center

Birmingham, Alabama, United States

Alaska Heart Institute

Anchorage, Alaska, United States

Hoag Hospital Newport Beach

Newport Beach, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Tallahassee Research Institute Inc

Tallahassee, Florida, United States

BayCare Medical Group Cardiology

Tampa, Florida, United States

Wellstar Research Institute

Marietta, Georgia, United States

Krannert Institute of Cardiology

Indianapolis, Indiana, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Our Lady of the Lake Office of Research

Baton Rouge, Louisiana, United States

Southcoast Health System

New Bedford, Massachusetts, United States

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

HealthEast Saint Josephs Hospital

Saint Paul, Minnesota, United States

Bryan Heart

Lincoln, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Integris Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Lehigh Valley Health

Allentown, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Countries

United States

References

Andrade JG, Moss JWE, Kuniss M, Sadri H, Wazni O, Sale A, Ismyrloglou E, Chierchia GB, Kaplon R, Mealing S, Bainbridge J, Bromilow T, Lane E, Khaykin Y. The Cost-Effectiveness of First-Line Cryoablation vs First-Line Antiarrhythmic Drugs in Canadian Patients With Paroxysmal Atrial Fibrillation. Can J Cardiol. 2024 Apr;40(4):576-584. doi: 10.1016/j.cjca.2023.11.019. Epub 2023 Nov 23.

Reference Type: DERIVED

PMID: 38007219 (View on PubMed)

Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.

Reference Type: DERIVED

PMID: 33197158 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Version 4

View Document

Document Type: Study Protocol: Version 5

View Document

Document Type: Study Protocol: Version 6

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT16012AFS001

Identifier Type: -

Identifier Source: org_study_id