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STOP Persistent AF

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: NCT03012841
Recruitment Status : Completed
First Posted : January 6, 2017
Results First Posted : August 21, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Arctic Front Advance Cardiac CryoAblation Catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STOP Persistent AF
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : August 13, 2019
Actual Study Completion Date : August 13, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Freezor MAX Cardiac CryoAblation Catheter


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. [ Time Frame: 12 Months ]

    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

  2. Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. [ Time Frame: 12 months ]

    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)


Secondary Outcome Measures :
  1. Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) [ Time Frame: Baseline and 12 months ]
    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).

  2. Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component [ Time Frame: Baseline and 12 months ]
    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).

  3. Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component [ Time Frame: Baseline and 12 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03012841


Locations
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Hugh Calkins, MD Johns Hopkins University
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
Statistical Analysis Plan  [PDF] July 8, 2019
Study Protocol: Version 4  [PDF] November 10, 2016
Study Protocol: Version 5  [PDF] April 17, 2017
Study Protocol: Version 6  [PDF] December 1, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03012841    
Other Study ID Numbers: STOP Persistent AF
First Posted: January 6, 2017    Key Record Dates
Results First Posted: August 21, 2020
Last Update Posted: October 8, 2020
Last Verified: September 2020
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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes