VT Ablation in the iCMR

Not Applicable

Recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Device: Vision-MR Ablation Catheter 2.0

• Registration Number: NCT05543798
• Lead Sponsor: Imricor Medical Systems

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Status Verified: 2025-04
• Study Start: 2025-04-10
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Randomized	Vision-MR Ablation Catheter 2.0	All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint	Perioperative/Periprocedural	Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0
Primary Safety Endpoint	7 days	Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Endpoint	6 months	Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.

Trial Locations

Locations (3)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

HagaZiekenhuis; 🇳🇱 Den Haag, Netherlands