STOP Persistent AF

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Arctic Front Advance Cardiac CryoAblation Catheter

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 1Z4
      • Victoria Cardiac Arrhythmia Trials
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
• Japan
  • Tokyo, Japan
    • Jikei University Hospital
  • Yokohama, Japan, 231-8682
    • Yokohama City Minato Red Cross Hospital
  • Tokyo
    • Bunkyō, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner-University Medical Center Phoenix
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Cardiac Arrhythmia Service
    • Jacksonville, Florida, United States, 32204
      • Saint Vincent's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Evanston, Illinois, United States, 60201-1718
      • Northshore University Health System
  • Maryland
    • Baltimore, Maryland, United States, 21287-0005
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Health System
  • New Jersey
    • Englewood, New Jersey, United States, 07631-1808
      • Englewood Hospital & Medical Center
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10075-1851
      • Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Health Cardiology
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Research Institute
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
• Failure or intolerance of at least one Class I or III antiarrhythmic drug
• Age 18 or older (or older than 18 if required by local law)

Exclusion Criteria:

• Left atrial diameter > 5.0 cm (anteroposterior)
• Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
• 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) within 12 months
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Presence of any cardiac valve prosthesis
• +3 and +4 mitral valve regurgitation or stenosis
• Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
• Unstable angina
• New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
• Primary pulmonary hypertension
• Rheumatic heart disease
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• Active systemic infection
• Hypertrophic cardiomyopathy
• Cryoglobulinemia
• Uncontrolled hyperthyroidism
• Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
• Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
• Life expectancy less than one year
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
• Known allergies or hypersensitivities to adhesives
• Known drug or alcohol dependency
• Unwilling or unable to comply fully with study procedures and follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter	Device: Arctic Front Advance Cardiac CryoAblation Catheter; Cryoablation; Other Names: Freezor MAX Cardiac CryoAblation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.	Treatment failure is defined as any of the following components: Acute procedural failure; Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period; A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period; Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.; Ablation using radiofrequency (RF) in the left atrium Blanking period is defined as the first 90 days after the index ablation procedure. Acute procedural failure is defined as: Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure; Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers	12 Months
Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.	A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following: Transient ischemic attack (within 7 days of ablation procedure); Cerebrovascular accident (within 7 days of ablation procedure); Major bleeding that requires transfusion (within 7 days of ablation procedure); Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure); Pulmonary vein stenosis (> 75% reduction within 12-months of ablation procedure); Myocardial infarction (within 7 days of ablation procedure); Phrenic nerve injury (unresolved at 12-months); Atrio-esophageal fistula (within 12-months of ablation procedure); Death (within 7 days of ablation procedure)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)	Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF).	Baseline and 12 months
Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component	Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).	Baseline and 12 months
Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component	Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions
• Investigators: Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai; Principal Investigator: Hugh Calkins, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): August 13, 2019
• Study Completion (Actual): August 13, 2019

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimated): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STOP Persistent AF

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