Endo-epicardial versus endocardial catheter ablation for post-heart attack ventricular tachycardia

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

The trial compares two interventional approaches for post-myocardial infarction ventricular tachycardia: standard endocardial-only ablation versus a combined endo-epicardial ablation that accesses the pericardial space. In the endo-epicardial group a pericardial puncture is performed after filling the space with carbon dioxide to create a safer working area. Procedures use standard electrophysiology systems and ablation catheters available at participating centers. Patients protected by an implantable cardioverter-defibrillator will be treated and followed for procedural safety and rates of VT recurrence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Status after myocardial infarction (minimum 3 months before inclusion in the study).
* Documented post-infarction VT or VF.
* Implantable ICD (at least 2 weeks before ablation) or CRT-D (at least 2 months before ablation).
* A history of at least one from below:

  1. One or more high energy interventions.
  2. Three or more adequate antitachycardia pacing therapies, including one symptomatic.
  3. Three or more episodes of VT in 24 hours (interrupted by ATP or shock) - electrical storm.
  4. Sustained VT recorded on ECG with a cycle length longer than the ICD detection threshold.
* Age between 18 and 85 years.
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Obesity with BMI \> 40 kg/m2.
* Left ventricle ejection fraction \< 20%.
* Pregnancy or breastfeeding.
* Renal failure (eGFR \< 20 mL/min/1.73m2).
* Fresh ballot thrombus in the left ventricle.
* Suspicion of massive adhesions in the pericardium that may impede pericardial puncture.
* Ablation of the post-infarction VT in the left ventricle in medical history.
* Previous heart surgery.
* Acute conditions that prevent ablation (including active infection, overt hyperthyroidism and others listed below).
* Active neoplastic disease.
* Heart failure with NYHA IV.
* Life expectancy less than 12 months.

Where it's running

• Medicover Hospital
  Warsaw, Masovian Voivodeship, Poland Recruiting
• Medical University of Warsaw
  Warsaw, Masovian Voivodeship, Poland Recruiting
• National Institute of Cardiology
  Warsaw, Masovian Voivodeship, Poland Not yet recruiting
• University Hospital No. 1 in Bydgoszcz
  Bydgoszcz, Poland Not yet recruiting
• University Clinical Center based in Gdańsk
  Gdansk, Poland Not yet recruiting
• Independent Public Health Care Facility University Hospital in Krakow
  Krakow, Poland Not yet recruiting

Study contacts

• Study coordinator: Derejko P Prof. Paweł Derejko, MD, PhD
• Email: pawel.derejko@medicover.pl
• Phone: +48 603338871

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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.