Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT) - Multicenter, Prospective, Randomized Trial
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The EPISODE VT trial is designed to compare efficacy and safety of two modalities for interventional treatment - endocardial ablation and endo-epicardial ablation in a population of patients with post myocardial infarction (ICD 10 - I25.2) ventricular tachycardias (ICD 10 - I47.2), who are protected by an implantable cardioverter-defibrilator (ICD) and meet study inclusion criteria.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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:
‣ One or more high energy interventions.
⁃ Three or more adequate antitachycardia pacing therapies, including one symptomatic.
⁃ Three or more episodes of VT in 24 hours (interrupted by ATP or shock) - electrical storm.
⁃ 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.
Locations
Other Locations
Poland
University Hospital No. 1 in Bydgoszcz
NOT_YET_RECRUITING
Bydgoszcz
University Clinical Center based in Gdańsk
NOT_YET_RECRUITING
Gdansk
Independent Public Health Care Facility University Hospital in Krakow
NOT_YET_RECRUITING
Krakow
University Clinical Hospital in Poznań
NOT_YET_RECRUITING
Poznan
University Clinical Hospital No. 2 PUM in Szczecin
NOT_YET_RECRUITING
Szczecin
Grochowski Hospital named after Dr. Rafał Masztak, MD
NOT_YET_RECRUITING
Warsaw
Medical University of Warsaw
RECRUITING
Warsaw
Medicover Hospital
RECRUITING
Warsaw
National Institute of Cardiology
NOT_YET_RECRUITING
Warsaw
Contact Information
Primary
Derejko P Prof. Paweł Derejko, MD, PhD
pawel.derejko@medicover.pl
+48 603338871
Backup
Fabijańska M Project Manager for Clinical Trials in Medicover Hospital
magdalena.fabijanska@medicover.pl
+48 519532444
Time Frame
Start Date:2025-02-03
Estimated Completion Date:2030-11-30
Participants
Target number of participants:220
Treatments
Active_comparator: Endocardial post MI VT ablation group
Endocardial post MI VT radiofrequency ablation using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators.
Experimental: Endo-epicaridal post MI VT ablation group
Endo-epicardial post-myocardial infarction VT radiofrequency ablation will be performed using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. Access to the pericardial sac will be preceded by CO2 insufflation into its lumen.