Atrial Flutter Ablation in the iCMR
ConditionAtrial Flutter Typical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImricor Medical Systems
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
Patient 18 years and older
Disqualifiers
Contraindications for MRI procedures
Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure
Previous CTI ablation procedures
Myocardial infarction within 60 days of enrollment
Trial design
Design model
Single group
Treatments tested in this trial
RF Ablation
DeviceRF ablation for type I atrial flutter under iCMR guidance
Treatment groups
91 Participants
are divided into 1 treatment groupGroup A: Vision-MR Atrial Flutter AblationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 point2
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 procedureSecondary outcomes
1
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)2
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)Sponsors and contacts
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Source ClinicalTrials.gov