The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
RF ablation for type I atrial flutter under iCMR guidance
Johns Hopkins University (JHU)
Baltimore, Maryland, United States
RECRUITINGUniversity of Virginia (UVA)
Charlottesville, Virginia, United States
NOT_YET_RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
Primary Efficacy Endpoint: Bi-directional block confirmation
Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator \& irrigation pump.
Time frame: Time of procedure, following delivery of last ablation energy delivery point
Primary Safety Endpoint: Composite of serious cardiovascular adverse events
A composite of the following serious adverse events as adjudicated by an independent clinical events committee: * Cardiac perforation/tamponade * Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Complete heart block * Myocardial infarction * Pulmonary embolism * MR-related serious adverse events * Unanticipated device related serious adverse events * Death
Time frame: 7-days post procedure
Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days
The percent of subjects free of documented type I atrial flutter recurrence
Time frame: 3 months (90 days)
Chronic Safety Endpoint: all serious adverse event rate for duration of study
Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee
Time frame: 3 months (90 days)
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l'institut Cardiologique Paris Sud (ICPS)
Massy, France
RECRUITINGAmsterdam University Medical Center (AUMC)
Amsterdam, Netherlands
RECRUITINGUniversity Hospital of Vaud (CHUV)
Lausanne, Switzerland
RECRUITING