Radiofrequency ablation for ventricular tachycardia in patients with ischemic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of radiofrequency ablation using the Vision-MR Ablation Catheter 2.0 for treating ventricular tachycardia in patients with ischemic cardiomyopathy. It is a prospective, single-arm, multi-center intervention that focuses on patients who have experienced spontaneous episodes of sustained ventricular tachycardia. The study aims to provide a new therapeutic option for patients who are refractory to antiarrhythmic drug therapy. Participants will be monitored for outcomes related to the procedure's effectiveness and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• HagaZiekenhuis
  The Hague, Netherlands Recruiting
• Herzzentrum Leipzig
  Leipzig, Saxony, Germany Not yet recruiting

Study contacts

• Study coordinator: Kate Lindborg, Phd
• Email: kate.lindborg@imricor.com
• Phone: 9528188400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.