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STOP Persistent AF PAS

NCT05005949

Active Not RecruitingN/A

Sponsor: Medtronic Cardiac Ablation Solutions

Conditions: Persistent Atrial Fibrillation

Interventions: Arctic Front™ Cardiac Cryoablation Catheter System

Countries: United States, Austria, Germany, Italy, Poland, United Kingdom

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Subject has been diagnosed with persistent AF.
* Subject is ≥ 18 years of age or minimum age as required by local regulations.
* Planned pulmonary vein isolation (PVI) procedure using 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:

* 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.

Locations (17)

Hartford, Connecticut, United States
Stamford, Connecticut, United States
Clearwater, Florida, United States
Davie, Florida, United States
Urbana, Illinois, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Cincinnati, Ohio, United States
Austin, Texas, United States
Dallas, Texas, United States
Linz, Austria
Cologne, Germany
Frankfurt am Main, Germany
München, Germany
Pisa, Italy
Lodz, Poland
Liverpool, United Kingdom