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NCT Number: NCT05543798

VT Ablation in the iCMR

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum Leipzig, Leipzig, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vision-MR Ablation Catheter 2.0

Device

Catheter ablation of ventricular tachycardia

Primary outcomes

  1. Primary Efficacy Endpoint

    Time frame: Perioperative/Periprocedural

    Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0

  2. Primary Safety Endpoint

    Time frame: 7 days

    Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure

Secondary outcomes

  1. Secondary Efficacy Endpoint

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Lindborg, Phd

CONTACT

[email protected]

9528188400

Sponsors and collaborators

Lead sponsor

Imricor Medical Systems

Industry

Registry information

Official study title

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

Acronym: VISABL-VT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 16, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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