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

Atrial Fibrillation Clinical Trial

— STOP AF First  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118518
• Other study ID #: MDT16012AFS001
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: June 25, 2020

Study information

• Verified date: July 2021
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Device:
• Cryoablation
Pulmonary vein isolation via ablation with cryoballoon catheter

Drug:
• Antiarrhythmic drug
Antiarrhythmic drug initiation

Locations

Country	Name	City	State
United States	Lehigh Valley Health	Allentown	Pennsylvania
United States	Alaska Heart Institute	Anchorage	Alaska
United States	University of Michigan Health System - University Hospital	Ann Arbor	Michigan
United States	Our Lady of the Lake Office of Research	Baton Rouge	Louisiana
United States	Grandview Medical Center	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	Bryan Heart	Lincoln	Nebraska
United States	Wellstar Research Institute	Marietta	Georgia
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Southcoast Health System	New Bedford	Massachusetts
United States	Hoag Hospital Newport Beach	Newport Beach	California
United States	Integris Baptist Medical Center, Inc.	Oklahoma City	Oklahoma
United States	Providence Saint Vincent Medical Center	Portland	Oregon
United States	The Valley Hospital	Ridgewood	New Jersey
United States	HealthEast Saint Josephs Hospital	Saint Paul	Minnesota
United States	Tallahassee Research Institute Inc	Tallahassee	Florida
United States	BayCare Medical Group Cardiology	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Randomization to 12 months
Primary	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).	Randomization to 12 months
Secondary	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.	Baseline and 12 Months
Secondary	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.	Initial treatment through 12 months.