Atrial Flutter Ablation in the iCMR
- Conditions
- Atrial Flutter Typical
- Interventions
- Device: RF Ablation
- Registration Number
- NCT05904548
- Lead Sponsor
- Imricor Medical Systems
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 91
- 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
- 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
- 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 right atrium 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vision-MR Atrial Flutter Ablation RF Ablation Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint: Bi-directional block confirmation Time of procedure, following delivery of last ablation energy delivery point Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator \& irrigation pump.
Primary Safety Endpoint: Composite of serious cardiovascular adverse events 7-days post procedure 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
- Secondary Outcome Measures
Name Time Method Chronic Safety Endpoint: all serious adverse event rate for duration of study 3 months (90 days) Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee
Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days 3 months (90 days) The percent of subjects free of documented type I atrial flutter recurrence
Trial Locations
- Locations (4)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
l'institut Cardiologique Paris Sud (ICPS)
🇫🇷Massy, France
Amsterdam University Medical Center (UMC)
🇳🇱Amsterdam, Netherlands
University Hospital of Vaud (CHUV)
🇨🇭Lausanne, Switzerland