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

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ClinicalTrials.gov Identifier: NCT03118518
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE June 16, 2017
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • Primary efficacy endpoint - Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter. [ Time Frame: Randomization to 12 months ]
    Measured by success or failure.
  • Primary safety endpoint - Rate of composite list of serious adverse events. [ Time Frame: Randomization to 12 months ]
    Measured by rate of composite list of serious adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Official Title  ICMJE STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Fibrillation New Onset
Intervention  ICMJE
  • Device: Cryoablation
    Pulmonary vein isolation via ablation with cryoballoon catheter
    Other Name: ArcticFront Advance Cardiac CryoAblation Catheter
  • Drug: Antiarrhythmic drug
    Antiarrhythmic drug initiation
Study Arms  ICMJE
  • Active Comparator: Anti-arrhythmic drug
    Intervention: Drug: Antiarrhythmic drug
  • Experimental: Cryoablation
    Intervention: Device: Cryoablation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 25, 2020
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118518
Other Study ID Numbers  ICMJE MDT16012AFS001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP