STOP AF First Post-Approval Study

Purpose

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

Condition

  • Paroxysmal Atrial Fibrillation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 at least 7 calendar days post study enrollment to allow for pre-ablation baseline data collection from sensor device - 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 class I or III antiarrhythmic drug (AAD), including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days prior to planned PVI procedure or with the intention to convert an AF episode are allowed. - 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Sarfraz Durrani, MD
240-393-8901
Sarfraz.a.durrani@medstar.net

More Details

Status
Recruiting
Sponsor
Medtronic Cardiac Rhythm and Heart Failure

Study Contact

Ryan Radtke
712.941.9372
ryan.s.radtke@medtronic.com

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.