RecruitingNot ApplicableNCT05904548
Atrial Flutter Ablation in the iCMR
Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
Sponsor
Imricor Medical Systems
Enrollment
91 participants
Start Date
Jun 20, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria21
- 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
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Interventions
DEVICERF Ablation
RF ablation for type I atrial flutter under iCMR guidance
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT05904548