Phase
Condition
Arrhythmia
Atrial Fibrillation
Atrial Flutter
Treatment
RF Ablation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient indicated for type I atrial flutter ablations with at least 1 documentedepisode of type I atrial flutter within 6 months (180 days) of enrollment
Patient 18 years and older
Exclusion
Exclusion Criteria:
Contraindications for MRI procedures
Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed forthe treatment of type I atrial flutter stopped on the day of the procedure
Previous CTI ablation procedures
Myocardial infarction within 60 days of enrollment
Current unstable angina
Cardiac surgery within 90 days of enrollment
Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment
Thrombocytosis or thrombocytopenia
Contraindication to anticoagulation therapy
Currently documented intracardiac thrombus or myxoma
Implantation of permanent leads of an implantable device in or through the rightatrium within 90 days of enrollment
Prosthetic valve through which the catheter must pass
Interatrial baffle or patch through which the catheter must pass
Moderate or severe tricuspid valve regurgitation or stenosis
Uncompensated congestive heart failure
Active systemic infection
Pregnancy or if subject plans to become pregnant during the trial
Uncontrolled hyperthyroidism
Any other significant uncontrolled or unstable medical condition
Enrollment in any concurrent study without Imricor written approval
Life expectancy of less than or equal to 2 years (730 days) per physician opinion
Study Design
Connect with a study center
l'institut Cardiologique Paris Sud (ICPS)
Massy, 91300
FranceSite Not Available
l'institut Cardiologique Paris Sud (ICPS)
Massy 2995206, 91300
FranceActive - Recruiting
Amsterdam University Medical Center (UMC)
Amsterdam,
NetherlandsSite Not Available
Amsterdam University Medical Center (AUMC)
Amsterdam 2759794,
NetherlandsActive - Recruiting
University Hospital of Vaud (CHUV)
Lausanne, 1011
SwitzerlandSite Not Available
University Hospital of Vaud (CHUV)
Lausanne 2659994, 1011
SwitzerlandActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21218
United StatesSite Not Available
Johns Hopkins University (JHU)
Baltimore 4347778, Maryland 4361885 21218
United StatesActive - Recruiting
University of Virginia (UVA)
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23284
United StatesSite Not Available

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