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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03118518
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Fibrillation New Onset Device: Cryoablation Drug: Antiarrhythmic drug Not Applicable

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 cryoballon catheter.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Anti-arrhythmic drug Drug: Antiarrhythmic drug
Antiarrhythmic drug initiation

Experimental: Cryoablation Device: Cryoablation
Pulmonary vein isolation via ablation with cryoballon catheter
Other Name: ArcticFront Advance Cardiac CryoAblation Catheter




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118518


  Show 24 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Oussama Wazni, MD The Cleveland Clinic
Principal Investigator: Gopi Dandamudi, MD Indianua University Krannert Institute of Cardiology
Principal Investigator: Steve Nissen, MD The Cleveland Clinic

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03118518     History of Changes
Other Study ID Numbers: MDT16012AFS001
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents