Comparing two methods of catheter ablation for ventricular tachycardia in heart disease patients

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 effectiveness of endo-epicardial catheter ablation compared to traditional endocardial-only ablation for treating ventricular tachycardia in patients with ischemic cardiomyopathy. The study aims to address the high recurrence rates of ventricular tachycardia by targeting both the endocardial and epicardial layers of the heart. Patients will undergo their first radiofrequency ablation procedure, and the outcomes will be monitored to assess the success of the different approaches. The trial includes patients with implantable cardioverter-defibrillators and requires informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients over 18 years of age
2. 1st radiofrequency ablation of VT complicating ischaemic heart disease
3. Patients with an ICD and remote monitoring
4. Having, for women of childbearing age, effective contraception until discharge from hospital
5. Have given their free and informed consent in writing
6. are affiliated to or have health insurance

Exclusion Criteria:

1. History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)
2. Presence of a left intraventricular thrombus found during pre-procedure imaging
3. Anticoagulant therapy that cannot be temporarily discontinued
4. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy
5. History of pericarditis
6. Previous thoracic radiotherapy
7. Contraindication to general anaesthesia
8. Pregnant or breastfeeding woman
9. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)
10. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

Where it's running

• Centre Hospitalier de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• CHU de Nantes
  Nantes, France Recruiting
• Hôpital Européen Georges Pompidou
  Paris, France Recruiting
• CHU de Rennes
  Rennes, France Recruiting
• CHU de Bordeaux
  Bordeaux, France Not yet recruiting
• Centre Hospitalier Universitaire de Caen
  Caen, France Not yet recruiting

Study contacts

• Principal investigator: Raphaël MARTINS, MD, PhD — Rennes University Hospital
• Study coordinator: Raphaël MARTINS, MD, PhD
• Email: raphael.martins@chu-rennes.fr
• Phone: 299282517

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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.