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Clinical Trials in the Netherlands / NCT05904548
Recruiting Not applicable

Atrial Flutter Ablation in the iCMR

NCT05904548 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Imricor Medical Systems
Phase
Not applicable
Started
2024-06-20
Last updated
2026-04-13

Condition(s) studied

Atrial Flutter Typical

Investigational drug(s) / intervention(s)

RF Ablation

RF Ablation: RF ablation for type I atrial flutter under iCMR guidance

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Johns Hopkins University (JHU) Baltimore Maryland Recruiting
University of Virginia (UVA) Charlottesville Virginia Not Yet Recruiting
Virginia Commonwealth University Richmond Virginia Not Yet Recruiting
l'institut Cardiologique Paris Sud (ICPS) Massy France Recruiting
Amsterdam University Medical Center (AUMC) Amsterdam Netherlands Recruiting
University Hospital of Vaud (CHUV) Lausanne Switzerland Recruiting

More Imricor Medical Systems trials in the Netherlands

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05904548 on ClinicalTrials.gov ↗ ← All trials in the Netherlands