Trials / Recruiting
RecruitingNCT05904548
Atrial Flutter Ablation in the iCMR
Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 91 (estimated)
- Sponsor
- Imricor Medical Systems · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RF Ablation | RF ablation for type I atrial flutter under iCMR guidance |
Timeline
- Start date
- 2024-06-20
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2023-06-15
- Last updated
- 2026-04-13
Locations
6 sites across 4 countries: United States, France, Netherlands, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05904548. Inclusion in this directory is not an endorsement.