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

NCT03118518 | Completed Results FDA Device

• 1 other identifier: MDT16012AFS001
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 24

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.

Conditions

Atrial Fibrillation; Atrial Fibrillation New Onset

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter.

  Treatment success after AAD initiation (control arm) or pulmonary vein isolation ablation procedure utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter (treatment arm). Treatment success is the opposite of treatment failure. Treatment failure was defined as any of the following: * Acute procedural failure (treatment arm only). * Documented AF/AT/AFL on ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm). Minimum of 30 seconds on ambulatory monitoring or 10 seconds on 12-lead ECG. * Any subsequent AF surgery or ablation in the left atrium. * Any subsequent cardioversion after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm). * Class I or III antiarrhythmic drug (or sotalol) use after the 90-day blanking period (treatment arm only).

  Randomization to 12 months

• Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.

  Measured by rate of composite list of serious adverse events in cryoablation-treated as randomized arm. Includes: * TIA within 7 days * Cerebrovascular accident within 7 days * Major bleed that requires transfusion or results in a 20% or greater fall in hematocrit (HCT) within 7 days * Development of a significant pericardial effusion within 30 days. (One that results in hemodynamic compromise, requires elective or urgent pericardiocentesis, or results in a 1-cm or more pericardial effusion as documented by echocardiography). * Symptomatic PV stenosis within 12 months; accompanied by one of the following: 50%-75% reduction in diameter of the pulmonary vein, with symptoms not explained by other conditions; OR \>75% reduction in diameter of the pulmonary vein * MI within 7 days * PNI unresolved at 12 months * AE fistula within 12 months * Major vascular complication that requires intervention, prolongs hospital stay, or requires hospital admission (within 7 days).

  Randomization to 12 months

Secondary Outcomes (2)

• Quality of Life Scores at Baseline Compared to 12 Months

  Baseline and 12 Months

• Healthcare Utilization

  Initial treatment through 12 months.

Study Arms (2)

Anti-arrhythmic drug

ACTIVE COMPARATOR

Drug: Antiarrhythmic drug

Cryoablation

EXPERIMENTAL

Device: Cryoablation

Interventions

Cryoablation DEVICE

Pulmonary vein isolation via ablation with cryoballoon catheter

Also known as: ArcticFront Advance Cardiac CryoAblation Catheter

Cryoablation

Antiarrhythmic drug DRUG

Antiarrhythmic drug initiation

Anti-arrhythmic drug

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (24)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Alaska Heart Institute

Anchorage, Alaska, 50266-8209, United States

Location

Hoag Hospital Newport Beach

Newport Beach, California, 92663, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010-3017, United States

Location

Tallahassee Research Institute Inc

Tallahassee, Florida, 32308-4646, United States

Location

BayCare Medical Group Cardiology

Tampa, Florida, 33607, United States

Location

Wellstar Research Institute

Marietta, Georgia, 30060, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266-8209, United States

Location

Our Lady of the Lake Office of Research

Baton Rouge, Louisiana, 50266-8209, United States

Location

Southcoast Health System

New Bedford, Massachusetts, 02740, United States

Location

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, 50266-8209, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

HealthEast Saint Josephs Hospital

Saint Paul, Minnesota, 55102-1062, United States

Location

Bryan Heart

Lincoln, Nebraska, 07450-2726, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450-2726, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195-0001, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Integris Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, 73112-4418, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Lehigh Valley Health

Allentown, Pennsylvania, 18105, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17821, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 50266-8209, United States

Location

Related Publications (2)

• 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.

  PMID: 38007219 DERIVED

• 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.

  PMID: 33197158 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery; Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Erika Pouliot
• Organization: Medtronic

erika.pouliot@medtronic.com

17635261270

Study Officials

• Oussama Wazni, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Gopi Dandamudi, MD

  Franciscan Heart & Vascular Associates at St. Joseph

  PRINCIPAL INVESTIGATOR

• Steve Nissen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 18, 2017
• Study Start: June 23, 2017
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: February 13, 2025
• Results First Posted: August 11, 2021

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)