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

Not Applicable

Completed

Conditions: Atrial Fibrillation
Atrial Fibrillation New Onset

Interventions: Device: Cryoablation
Drug: Antiarrhythmic drug

Registration Number: NCT03118518

Lead Sponsor: Medtronic Cardiac Ablation Solutions

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	-
Anti-arrhythmic drug	Antiarrhythmic drug	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Life Scores at Baseline Compared to 12 Months	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.
Healthcare Utilization	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.

Trial Locations

Locations (24): Grandview Medical Center
🇺🇸
Birmingham, Alabama, United States
Alaska Heart Institute
🇺🇸
Anchorage, Alaska, United States
Hoag Hospital Newport Beach
🇺🇸
Newport Beach, California, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Tallahassee Research Institute Inc
🇺🇸
Tallahassee, Florida, United States
BayCare Medical Group Cardiology
🇺🇸
Tampa, Florida, United States
Wellstar Research Institute
🇺🇸
Marietta, Georgia, United States
Krannert Institute of Cardiology
🇺🇸
Indianapolis, Indiana, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Our Lady of the Lake Office of Research
🇺🇸
Baton Rouge, Louisiana, United States
Scroll for more (14 remaining)
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States