STOP AF First Post-Approval Study

Description

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

Conditions

Paroxysmal Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

STOP AF First Post-Approval Study

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Anchorage

Alaska Heart Institute, Anchorage, Alaska, United States, 99508

Stamford

Cardiology Associates of Fairfield County, Stamford, Connecticut, United States, 06905-5522

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Clearwater

BayCare Medical Group Cardiology, Clearwater, Florida, United States, 33756

Davie

Heart Rhythm Solutions, Davie, Florida, United States, 33328

West Des Moines

Iowa Heart, West Des Moines, Iowa, United States, 50266

Baton Rouge

Our Lady of the Lake, Baton Rouge, Louisiana, United States, 70808

North Dartmouth

Southcoast Health System, North Dartmouth, Massachusetts, United States, 02747

Detroit

Henry Ford Heart & Vascular, Detroit, Michigan, United States, 48202-2608

Cincinnati

The Lindner Research Center, Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiac Rhythm and Heart Failure,

Khaldoun Tarakji, MD, STUDY_DIRECTOR, Medtronic CAS Chief Medical Officer

Study Record Dates

2028-01