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Clinical Trials in Germany / NCT05543798
Recruiting Not applicable

VT Ablation in the iCMR

NCT05543798 · tracked via the Priya Life Science Germany tracker
Sponsor
Imricor Medical Systems
Phase
Not applicable
Started
2025-04-10
Last updated
2026-01-08

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

Vision-MR Ablation Catheter 2.0

Vision-MR Ablation Catheter 2.0: Catheter ablation of ventricular tachycardia

Study summary

The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy 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: * Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy) * Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure * Diagnosis of Ischemic Cardiomyopathy * AAD therapy refractory, contraindicated, not tolerated, or not desired * 18 years or older Exclusion Criteria: * Implanted with non-MR compatible medical devices or contraindicated for an MRI * Presence of intracardiac thrombus (verified via CT/MRI/TEE/TTE within 48 hours of procedure - or at start of procedure) * Thrombocytopenia or coagulopathy * Mechanical mitral and/or aortic valve precluding access to the left ventricle * Severe aortic stenosis * Myocardial infarction requiring stent implantation within 90 days of procedure * Previous cardiac surgery within 60 days of procedures * Known/uncontrolled stroke risks * Class IV Heart Failure * Ejection Fraction (EF) \< 25% * Patients with a glomerular filtration rate (GFR) \< 30 * Women who are pregnant * Allergy to contrast agents (e.g., Gadolinium) * Active infection * Known or suspected myxoma * Unstable angina * Patients who do not tolerate anticoagulation therapy * Previous intertribal septal patch or prosthetic atrial septal defect closure device * Life expectancy \< 12 months * Enrollment in another study without sponsor approval

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Herzzentrum Leipzig Leipzig Saxony Not Yet Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
HagaZiekenhuis The Hague Netherlands Not Yet Recruiting

Other trials for the same condition

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 NCT05543798 on ClinicalTrials.gov ↗ ← All trials in Germany