RF Ablation: RF ablation for type I atrial flutter under iCMR guidance
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
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
Trial sites (6)
Facility
City
Region
Status
Johns Hopkins University (JHU)
Baltimore
Maryland
Recruiting
University of Virginia (UVA)
Charlottesville
Virginia
Not Yet Recruiting
Virginia Commonwealth University
Richmond
Virginia
Not Yet Recruiting
l'institut Cardiologique Paris Sud (ICPS)
Massy
France
Recruiting
Amsterdam University Medical Center (AUMC)
Amsterdam
Netherlands
Recruiting
University Hospital of Vaud (CHUV)
Lausanne
Switzerland
Recruiting
More Imricor Medical Systems trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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