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

Primary Purpose

Atrial Fibrillation, Atrial Fibrillation New Onset

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Antiarrhythmic drug
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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grandview Medical Center
  • Alaska Heart Institute
  • Hoag Hospital Newport Beach
  • MedStar Washington Hospital Center
  • Tallahassee Research Institute Inc
  • BayCare Medical Group Cardiology
  • Wellstar Research Institute
  • Krannert Institute of Cardiology
  • Iowa Heart Center
  • Our Lady of the Lake Office of Research
  • Southcoast Health System
  • University of Michigan Health System - University Hospital
  • Spectrum Health Hospitals
  • HealthEast Saint Josephs Hospital
  • Bryan Heart
  • Hackensack University Medical Center
  • The Valley Hospital
  • Cleveland Clinic
  • Ohio State University
  • Integris Baptist Medical Center, Inc.
  • Providence Saint Vincent Medical Center
  • Lehigh Valley Health
  • Geisinger Medical Center
  • Aurora Cardiovascular Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anti-arrhythmic drug

Cryoablation

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter.
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).
Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.
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

Quality of Life Scores at Baseline Compared to 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.
Healthcare Utilization
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.

Full Information

First Posted
April 4, 2017
Last Updated
July 20, 2021
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03118518
Brief Title
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Acronym
STOP AF First
Official Title
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-arrhythmic drug
Arm Type
Active Comparator
Arm Title
Cryoablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
ArcticFront Advance Cardiac CryoAblation Catheter
Intervention Description
Pulmonary vein isolation via ablation with cryoballoon catheter
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug
Intervention Description
Antiarrhythmic drug initiation
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter.
Description
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).
Time Frame
Randomization to 12 months
Title
Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.
Description
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).
Time Frame
Randomization to 12 months
Secondary Outcome Measure Information:
Title
Quality of Life Scores at Baseline Compared to 12 Months
Description
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.
Time Frame
Baseline and 12 Months
Title
Healthcare Utilization
Description
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.
Time Frame
Initial treatment through 12 months.

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oussama Wazni, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gopi Dandamudi, MD
Organizational Affiliation
Franciscan Heart & Vascular Associates at St. Joseph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Nissen, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Alaska Heart Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
50266-8209
Country
United States
Facility Name
Hoag Hospital Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-3017
Country
United States
Facility Name
Tallahassee Research Institute Inc
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-4646
Country
United States
Facility Name
BayCare Medical Group Cardiology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Wellstar Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Krannert Institute of Cardiology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-8209
Country
United States
Facility Name
Our Lady of the Lake Office of Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
50266-8209
Country
United States
Facility Name
Southcoast Health System
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
University of Michigan Health System - University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
50266-8209
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
HealthEast Saint Josephs Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102-1062
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
07450-2726
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450-2726
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Integris Baptist Medical Center, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4418
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lehigh Valley Health
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
50266-8209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33197158
Citation
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.
Results Reference
derived

Learn more about this trial

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

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