Clinical trial NCT05227053: STOP AF First Post-Approval Study
Official title: STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ cardiac cryoablation catheter System.

Brief summary: The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Detailed description: The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Eligibility criteria: Inclusion Criteria:

* Subject has been diagnosed with symptomatic paroxysmal AF
* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1

. Subjects under the following conditions may be included in the study:

1. Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of \<4 weeks prior to the index PVI procedure)
2. Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation
3. A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.

   * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
   * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
   * Subject with exclusion criteria required by local law

Primary outcomes:
measure: Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
timeFrame: 36 months
measure: Freedom from Primary Safety Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Stamford
country: United States
facility: Cardiology Associates of Fairfield County
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: BayCare Medical Group Cardiology
state: Florida
city: Davie
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart
state: Iowa
city: Baton Rouge
country: United States
facility: Our Lady of the Lake
state: Louisiana
city: North Dartmouth
country: United States
facility: Southcoast Health System
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Heart & Vascular
state: Michigan
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Methodist Physicians
state: Tennessee
city: Dallas
country: United States
facility: Texas Health Research and Education Institute
state: Texas
Study officials:
affiliation: Medtronic CAS Chief Medical Officer
name: Khaldoun Tarakji, MD
role: STUDY_DIRECTOR
References: