Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05888662 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)

Study acronym: EPIC-VT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion dates: Oct 23, 2028 to Oct 23, 2029
    • Study sites: 10 to 12
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 8 to 9
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2023 to Oct 23, 2023
    • Study sites: 0 to 10
    • Primary and study completion dates: Jun 1, 2028 to Oct 23, 2028
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV. First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial. For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences. The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.
Trial Details
NCT Number NCT05888662
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)
Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov