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Recruiting NCT05543798

VT Ablation in the iCMR

No phase Interventional Ventricular Tachycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vision-MR Ablation Catheter 2.0.
Who it may be relevant to
Registry conditions: Ventricular Tachycardia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Vision-MR Ablation Catheter 2.0
    Catheter ablation of ventricular tachycardia

Primary outcome measures

  • Primary Efficacy Endpoint [Time frame: Perioperative/Periprocedural]
  • Primary Safety Endpoint [Time frame: 7 days]
Secondary outcome measures (1)
  • Secondary Efficacy Endpoint [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 2 centers
  • Amsterdam UMC — Amsterdam
  • HagaZiekenhuis — The Hague
Germany · 1 center
  • Herzzentrum Leipzig — Leipzig

Identifiers

NCT: NCT05543798 · VISABL-VT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗