The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
NCT ID: NCT06324201
Last Updated: 2025-10-31
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
250 participants
OBSERVATIONAL
2024-02-27
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Interventions
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Ablation Procedure
Ablation Procedure for paroxysmal atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older
3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
4. Willing and able to provide informed consent for this sub-study
Exclusion Criteria
2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
3. Persistent or long-standing persistent AF
4. In the opinion of the investigator, any known contraindication to an ablation procedure
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Heart Rhythm Clinical and Research Solutions, LLC
OTHER
Responsible Party
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Principal Investigators
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Brian Sanchez, MD
Role: STUDY_DIRECTOR
J & J Corporation
Locations
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Arrhythmia Institute at Grandview
Birmingham, Alabama, United States
Mobile Cardiology Associates
Mobile, Alabama, United States
Community Memorial Health System
Ventura, California, United States
Medical City - HCA
Aurora, Colorado, United States
Naples Community Hospital
Naples, Florida, United States
Sarasota Memorial Health
Sarasota, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, United States
The Brigham and Womens Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Trinity Health-Michigan Heart
Ypsilanti, Michigan, United States
The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania (UPENN)
Philadelphia, Pennsylvania, United States
Allegheny Health
Pittsburgh, Pennsylvania, United States
Centra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
Bon Secours Medical Group - Richmond Specialty Care
Richmond, Virginia, United States
Valley Health System
Winchester, Virginia, United States
Multicare Health Systems-Pulse Heart
Puyallup, Washington, United States
Franciscan Heart and Vascular Associates
Tacoma, Washington, United States
Mercy Health
Janesville, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Cindy Baumann
Role: primary
Kaitlyn Phetteplace
Role: primary
Other Identifiers
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QDOT PAS
Identifier Type: -
Identifier Source: org_study_id
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