Atrial Flutter Typical
Conditions
Keywords
RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)
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.
Interventions
DEVICERF Ablation
RF ablation for type I atrial flutter under iCMR guidance
Sponsors
Imricor Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France, Netherlands, Switzerland, United States
Contacts
CONTACTKate Lindborg
CONTACTJennifer Somerville
STUDY_DIRECTORKate Lindborg
Imricor Medical Systems, Inc.
Outcome results
None listed