Radiofrequency ablation for ventricular tachycardia in patients with ischemic cardiomyopathy
Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
This study is testing a new procedure using radiofrequency ablation to see if it can safely help people with ischemic cardiomyopathy who have frequent episodes of fast heartbeats that don't respond to medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imricor Medical Systems Industry-sponsored |
| Locations | 3 sites (Leipzig, Saxony and 2 other locations) |
| Trial ID | NCT05543798 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented ventricular tachycardia and ischemic cardiomyopathy who are not responding to or cannot tolerate antiarrhythmic drugs.
Not a fit: Patients with non-MR compatible medical devices, recent cardiac surgery, or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart rhythm control and quality of life for patients with ischemic cardiomyopathy.
How similar studies have performed: Other studies have shown promising results with radiofrequency ablation for ventricular tachycardia, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leipzig, Saxony and 2 other locations
- Herzzentrum Leipzig — Leipzig, Saxony, Germany (Not_yet_recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- HagaZiekenhuis — The Hague, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Kate Lindborg, Phd
- Email: kate.lindborg@imricor.com
- Phone: 9528188400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.