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STOP Persistent AF

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arctic Front Advance Cardiac CryoAblation Catheter
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner-University Medical Center Phoenix
  • Colorado Heart and Vascular
  • Medical Center of the Rockies
  • Cardiac Arrhythmia Service
  • Saint Vincent's Medical Center
  • Northwestern University
  • NorthShore University Health System
  • The Johns Hopkins Hospital
  • Massachusetts General Hospital
  • St. Luke's Health System
  • Englewood Hospital & Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)
  • Asheville Cardiology Associates
  • Doylestown Health Cardiology
  • Vanderbilt University Medical Center
  • Baylor Research Institute
  • Virginia Mason Medical Center
  • Swedish Medical Center
  • Victoria Cardiac Arrhythmia Trials
  • London Health Sciences Centre
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • Tokyo Medical and Dental University
  • Jikei University Hospital
  • Yokohama City Minato Red Cross Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
December 22, 2016
Last Updated
September 14, 2020
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03012841
Brief Title
STOP Persistent AF
Official Title
STOP Persistent AF
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
August 13, 2019 (Actual)
Study Completion Date
August 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
Intervention Type
Device
Intervention Name(s)
Arctic Front Advance Cardiac CryoAblation Catheter
Other Intervention Name(s)
Freezor MAX Cardiac CryoAblation Catheter
Intervention Description
Cryoablation
Primary Outcome Measure Information:
Title
Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
Description
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
Time Frame
12 Months
Title
Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
Description
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).
Time Frame
Baseline and 12 months
Title
Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component
Description
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).
Time Frame
Baseline and 12 months
Title
Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component
Description
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).
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Calkins, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner-University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Colorado Heart and Vascular
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Cardiac Arrhythmia Service
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Saint Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1718
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0005
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Englewood Hospital & Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631-1808
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)
City
New York
State/Province
New York
ZIP/Postal Code
10075-1851
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Doylestown Health Cardiology
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Victoria Cardiac Arrhythmia Trials
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 1Z4
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Tokyo Medical and Dental University
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Jikei University Hospital
City
Tokyo
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital
City
Yokohama
ZIP/Postal Code
231-8682
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32590151
Citation
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.
Results Reference
derived

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STOP Persistent AF

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