Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : April 18, 2017
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
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 cryoballoon catheter.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 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 23, 2017
Actual Primary Completion Date : June 25, 2020
Actual Study Completion Date : June 25, 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 cryoballoon catheter
Other Name: ArcticFront Advance Cardiac CryoAblation Catheter




Primary Outcome Measures :
  1. Percentage of Participants With 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 ]

    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).

  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 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).


Secondary Outcome Measures :
  1. Quality of Life Scores at Baseline Compared to 12 Months [ Time Frame: Baseline and 12 Months ]

    There are two hypotheses tested in the objective, with separate hypothesis tests for (1) the difference in composite scores from the AFEQT questionnaire taken at baseline and 12 month visits, and (2) for the difference in composite scores for the EQ-5D questionnaire taken at baseline and 12-month visits.

    Composite AFEQT score is on a scale of zero to one hundred. Higher scores are better.

    Composite EQ-5D score is on a scale of zero to one. Higher scores are better.


  2. Healthcare Utilization [ Time Frame: Initial treatment through 12 months. ]
    Compare health care utilization between the treatment and control arms. There are two hypotheses tested in the objective, with separate hypothesis tests for: (1) the rate of total health care utilization events (cardiovascular-related hospitalizations, emergency room visits, or unscheduled office visits) over 12 months shown as freedom from cardiovascular health care utilization by treatment arm, and (2) freedom from cardioversions (electrical or pharmacological) over 12 months by treatment arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Locations
Show Show 24 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
Study Protocol: Version 4  [PDF] April 10, 2017
Study Protocol: Version 5  [PDF] December 5, 2017
Study Protocol: Version 6  [PDF] January 16, 2018
Statistical Analysis Plan  [PDF] May 9, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03118518    
Other Study ID Numbers: MDT16012AFS001
First Posted: April 18, 2017    Key Record Dates
Results First Posted: August 11, 2021
Last Update Posted: August 11, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents