Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-04-28
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Arctic Front™ Cardiac Cryoablation Catheter
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Eligibility Criteria
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Inclusion Criteria
* 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
. 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Khaldoun Tarakji, MD
Role: STUDY_DIRECTOR
Medtronic CAS Chief Medical Officer
Locations
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Alaska Heart Institute
Anchorage, Alaska, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
BayCare Medical Group Cardiology
Clearwater, Florida, United States
Heart Rhythm Solutions
Davie, Florida, United States
Iowa Heart
West Des Moines, Iowa, United States
Our Lady of the Lake
Baton Rouge, Louisiana, United States
Southcoast Health System
North Dartmouth, Massachusetts, United States
Henry Ford Heart & Vascular
Detroit, Michigan, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
University of Tennessee Methodist Physicians
Memphis, Tennessee, United States
Texas Health Research and Education Institute
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Joseph Tiano, MD
Role: primary
Sarfraz Durrani, MD
Role: primary
James Irwin, MD
Role: primary
Awais Humayun, MD
Role: primary
Denise Sorrentino, MD
Role: primary
Kenneth Civello, M.D
Role: primary
Nitesh Sood, MD
Role: primary
Waddah Maskoun, MD
Role: primary
Daniel Pelchovitz, MD
Role: primary
Eric Johnson, MD
Role: primary
Yehoshua Levine, M.D.
Role: primary
Charles Lampe, MD
Role: primary
Other Identifiers
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STOP AF First PAS
Identifier Type: -
Identifier Source: org_study_id