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
580 participants
OBSERVATIONAL
2024-11-04
2029-06-01
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
Study Groups
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Paroxysmal
Ablation using the PulseSelect™ PFA system
PulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Persistent
Ablation using the PulseSelect™ PFA system
PulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Interventions
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PulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Eligibility Criteria
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Inclusion Criteria
* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
* Patient is ≥ 18 years of age
* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
* Willing and able 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
* Prior left atrial catheter or surgical ablation
* Patient with life expectancy \< 36 months
* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved 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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Pikeville Medical Center
Whitesburg, Kentucky, United States
Southcoast Health System
Fall River, Massachusetts, United States
Beaumont Health System
Royal Oak, Michigan, United States
Nebraska Medical Center
Omaha, Nebraska, United States
The Valley Hospital
New York, New York, United States
Northwell Health Lenox Hill Hospital
New York, New York, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Mount Carmel Grove City Medical Center
Grove City, Ohio, United States
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania, United States
AnMed Health Center
Anderson, South Carolina, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Texas Health Research & Education Institute
Dallas, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Joseph Souza, MD
Role: primary
Nitesh Sood, MD
Role: primary
Ilana Kutinsky
Role: primary
Jason Payne, MD
Role: primary
Suneet Mittal, MD
Role: primary
Stavros Mountantonakis, MD
Role: primary
Gaurang Gandhi, MD
Role: primary
John Hummel
Role: primary
Jianqing Li, MD
Role: primary
Robert Sangrigoli, MD
Role: primary
Rick Henderson, MD
Role: primary
Rachel Kaplan, MD
Role: primary
Charles Lampe, MD
Role: primary
Michael Mangrum, MD
Role: primary
Other Identifiers
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PULSED AF PAS
Identifier Type: -
Identifier Source: org_study_id