Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-16
Brief Title:
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-DEF
Brief Summary:
Implantable cardioverter-defibrillators ICD are currently recommended for the primary prevention of sudden cardiac death SCD in patients with a remote 6 weeks myocardial infarction MI and a low 35 left ventricular ejection fraction LVEF
Ventricular tachycardia VT andor ventricular fibrillation VF which are responsible for most SCDs result from the presence of surviving myocytes embedded within fibrotic MI-scar The presence of these surviving myocytes as well as their specific arrhythmic characteristics is not captured by LVEF Hence the use of LVEF as a unique risk-stratifier of SCD results in a low proportion 17 to 31 of appropriate ICD device therapy at 2 years Consequently most patients with a prophylactic ICD do not present VTVF requiring ICD therapy prior to their first-ICD battery depletion Thus many patients are exposed to ICD complications such as inappropriate shocks without deriving any health benefit Therefore the current implantation strategy of prophylactic ICDs based on LVEF only needs to be improved in post-MI patients
Ventricular tachycardia VT andor ventricular fibrillation VF which are responsible for most SCDs result from the presence of surviving myocytes embedded within fibrotic MI-scar The presence of these surviving myocytes as well as their specific arrhythmic characteristics is not captured by LVEF Hence the use of LVEF as a unique risk-stratifier of SCD results in a low proportion 17 to 31 of appropriate ICD device therapy at 2 years Consequently most patients with a prophylactic ICD do not present VTVF requiring ICD therapy prior to their first-ICD battery depletion Thus many patients are exposed to ICD complications such as inappropriate shocks without deriving any health benefit Therefore the current implantation strategy of prophylactic ICDs based on LVEF only needs to be improved in post-MI patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None