VT Ablation in the iCMR (VISABL-VT)

Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Vision-MR Ablation Catheter 2.0

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Lindborg, Phd; Phone Number: 9528188400; Email: kate.lindborg@imricor.com

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Not yet recruiting
      • Herzzentrum Leipzig
      • Contact: Sebastian Hilbert
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Michiel Kemme; Phone Number: +31 020-4442244; Email: m.kemme@amsterdamumc.nl
  • The Hague, Netherlands, 2545 AA
    • Not yet recruiting
    • HagaZiekenhuis
    • Contact: Ivo Van Der Bilt, MD, PhD
    • Contact: Hemanth Ramanna, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Randomized; All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0	Device: Vision-MR Ablation Catheter 2.0; Catheter ablation of ventricular tachycardia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoint	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.	6 months

Collaborators and Investigators

• Sponsor: Imricor Medical Systems

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular
• Other Study ID Numbers: VISABL-VT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No