Clinical trial NCT03118518: STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Official title: STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation New Onset
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter.
timeFrame: Randomization to 12 months
measure: Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.
timeFrame: Randomization to 12 months
Secondary outcomes:
measure: Quality of Life Scores at Baseline Compared to 12 Months
timeFrame: Baseline and 12 Months
measure: Healthcare Utilization
timeFrame: Initial treatment through 12 months.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Newport Beach
country: United States
facility: Hoag Hospital Newport Beach
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tallahassee
country: United States
facility: Tallahassee Research Institute Inc
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group Cardiology
state: Florida
city: Marietta
country: United States
facility: Wellstar Research Institute
state: Georgia
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Office of Research
state: Louisiana
city: New Bedford
country: United States
facility: Southcoast Health System
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System - University Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Saint Paul
country: United States
facility: HealthEast Saint Josephs Hospital
state: Minnesota
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center, Inc.
state: Oklahoma
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Oussama Wazni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Franciscan Heart & Vascular Associates at St. Joseph
name: Gopi Dandamudi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Steve Nissen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.