Actively Recruiting
Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter in the iCMR Environment
Led by Imricor Medical Systems · Updated on 2026-04-13
91
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of radiofrequency (RF) ablation treatment for type I atrial flutter using the Vision-MR Ablation Catheter 2.0 in an interventional cardiac magnetic resonance (iCMR) environment. This prospective, single-arm, multi-center clinical trial aims to gather data on how well this device works and how safe it is for patients with this heart rhythm disorder. The study involves performing type I atrial flutter ablation using the Vision-MR Ablation Catheter 2.0 together with the Advantage-MR EP recorder and stimulator system within the iCMR setting. Participants will receive this treatment during the procedure, which is guided by magnetic resonance imaging to target the affected heart area precisely. Participants will be monitored during and after the procedure to confirm successful blockage of arrhythmia pathways and to track any serious cardiovascular adverse events up to 7 days post-procedure. Further follow-up at 90 days will evaluate the continued absence of atrial flutter episodes and monitor for any serious adverse events throughout the study duration. The trial will assess these clinical outcomes to understand the efficacy and safety of the RF ablation device.
CONDITIONS
Brief Title
Atrial Flutter Ablation in the iCMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Time of procedure
Participants undergo RF ablation for type I atrial flutter using the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
1 procedure visit (in-person)
Duration - 7 days for safety monitoring, up to 3 months for chronic efficacy and safety assessments
Participants are monitored for safety and efficacy after the ablation procedure.
Multiple follow-up visits including a 7-day safety visit and assessments up to 3 months
Trial Site Locations
Total: 6 locations
1
Johns Hopkins University (JHU)
Baltimore, Maryland, United States, 21218
Actively Recruiting
2
University of Virginia (UVA)
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Not Yet Recruiting
4
l'institut Cardiologique Paris Sud (ICPS)
Massy, France, 91300
Actively Recruiting
5
Amsterdam University Medical Center (AUMC)
Amsterdam, Netherlands
Actively Recruiting
6
University Hospital of Vaud (CHUV)
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
K
Kate Lindborg
J
Jennifer Somerville
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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