Status:
UNKNOWN
Preventive VT Substrate Ablation in Ischemic Heart Disease
Lead Sponsor:
Centro Medico Teknon
Conditions:
Ventricular Tachycardia
Ventricular Arrythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is saf...
Detailed Description
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac mag...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Chronic, stable ischemic heart disease, irrespectively of the LVEF.
- Life expectancy of \> 1 year with a good functional status.
- Documented scar AND a BZC mass \> 5.15 g as measured per LGE-CMR and automatic post-processing using the ADAS-3D LV (ADAS 3D Medical SL, Barcelona, Spain).
- Signed informed consent.
Exclusion
- Age \< 18 years.
- Pregnancy.
- Life expectancy of \< 1 year, or bad functional status (NYHA IV functional class).
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Previously documented sustained ventricular arrhythmias.
- Impossibility to perform a contrast-enhanced CMR study.
- Calculated BZC mass in the scarred tissue \< 5.15 g using the ADAS-3D LV software.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04675073
Start Date
June 1 2021
End Date
December 1 2025
Last Update
August 30 2023
Active Locations (1)
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1
Centro Medico Teknon
Barcelona, Spain, 08022