Phase
Condition
Chest Pain
Arrhythmia
Dysrhythmia
Treatment
Sphere-9™ Catheter and Affera™ Ablation System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longerthan 7 days but less than 12 months)
Refractory (i.e. not effective, not tolerated, or not desired) to at least one ClassI or III antiarrhythmic drug (AAD)
Patient is ≥ 18 years of age
Planned de novo pulmonary vein isolation procedure using commercially availableSphere-9™ Catheter and Affera Ablation System
Patient is willing and able to comply with study requirements and give informedconsent
Exclusion
Exclusion Criteria:
Long-standing persistent AF (continuous AF sustained >12 months)
Prior left atrial catheter or surgical ablation
Life expectancy <36 months
Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertablecardiac monitor (ICM), or any type of implantable cardiac defibrillator (with orwithout biventricular pacing function)
Current or anticipated participation in any other clinical trial of a drug, deviceor biologic during the duration of this study not pre-approved by Medtronic
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham Hospital
Birmingham, Alabama 35294
United StatesSite Not Available
University of Alabama at Birmingham Hospital
Birmingham 4049979, Alabama 4829764 35294
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
United StatesSite Not Available
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis 5037649, Minnesota 5037779 55407
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Montefiore Medical Center
New York, New York 10467
United StatesSite Not Available
Montefiore Medical Center
New York 5128581, New York 5128638 10467
United StatesSite Not Available
Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28230
United StatesSite Not Available
OhioHealth
Columbus, Ohio 43214
United StatesSite Not Available
OhioHealth
Columbus 4509177, Ohio 5165418 43214
United StatesSite Not Available
Doylestown Health Cardiology
Doylestown, Pennsylvania 18901
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Doylestown Health Cardiology
Doylestown 5187247, Pennsylvania 6254927 18901
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesSite Not Available
Texas Health Resources
Fort Worth, Texas 76104
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Texas Health Resources
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Virginia Medical Center
Charlottesville, Virginia 22903
United StatesSite Not Available
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia 24501
United StatesSite Not Available
University of Virginia Medical Center
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg 4771075, Virginia 6254928 24501
United StatesSite Not Available

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