Actively Recruiting
Atrial Flutter Ablation in the iCMR
Led by Imricor Medical Systems · Updated on 2026-04-13
91
Participants Needed
6
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
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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
CONTACT
J
Jennifer Somerville
CONTACT
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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