Atrial Flutter Ablation in the iCMR

Study Overview
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Brief Summary
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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.

Official Title
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Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter

Conditions
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Atrial Flutter Typical

Intervention / Treatment
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* Device: RF Ablation


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vision-MR Atrial Flutter Ablation<br>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. | Device: RF Ablation<br>* RF ablation for type I atrial flutter under iCMR guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 7-days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days | The percent of subjects free of documented type I atrial flutter recurrence | 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 | 3 months (90 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)