Atrial Flutter Ablation in the iCMR
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Imricor Medical Systems
- Study ID
- NCT05904548
- Status
- Recruiting
Conditions
- Atrial Flutter Typical
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RF Ablation — DEVICERF ablation for type I atrial flutter under iCMR guidance
Study Details
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.
Key Dates
- Start date
- Jun 20, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 91 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Vision-MR Atrial Flutter AblationType 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.
Primary Outcome Measure
Primary Safety Endpoint: Composite of serious cardiovascular adverse events [ Time Frame: 7-days post procedure ]
Central Contacts
- Kate Lindborg952-818-8400
- Jennifer Somerville952-594-4138
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins University (JHU) | Baltimore | Maryland | 21218 | Aravindan Kolandaivelu, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia (UVA) | Charlottesville | Virginia | 22903 | Kenneth Bilchick, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | Ajay Pillai, M.D. (PRINCIPAL_INVESTIGATOR) |