CHRU Nancy
Vandœuvre-lès-Nancy, 54511, France
Location contact
Christian de CHILLOU, MD, PhD
CONTACT
Guillaume DROUOT, PhD
CONTACT
NCT Number: NCT06269692
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) and/or 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 VT/VF 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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Vandœuvre-lès-Nancy, 54511, France
Christian de CHILLOU, MD, PhD
CONTACT
Guillaume DROUOT, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar
Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group
Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines
Time frame: 72 months
Occurrence of SCD during the follow-up period, as defined by the World Health Organization in 10-ICD: death occurring within 24 hours from onset of symptoms.
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Time frame: 72 months
Measurements of the estimated costs for the National Health Insurance System (NHIS) in the different arms of the trial
Time frame: 36 months
Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences, LGE segmentation by cardiologists/radiologists as the ground truth
Time frame: 36 months
Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences, LGE segmentation by cardiologists/radiologists as the ground truth
Time frame: 36 months
Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar, using manually corrected segmentation by cardiologists/radiologists as the ground truth
Time frame: 36 months
Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar, using manually corrected segmentation by cardiologists/radiologists as the ground truth
Contact information is provided by the study sponsor or research team.
Christian de CHILLOU, MD, PhD
CONTACT
Guilaume DROUOT, PhD
CONTACT
Central Hospital, Nancy, France
Other
Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Acronym: SMART-DEF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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