NCT03846297Recruiting
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 16 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imaging (MRI) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk. The secondary objective is to perform a medico-economic analysis of ICD implantation in order to define an optimal rule for ICD implantation in patients with HCM, taking into account the benefits of ICD, adverse effects of ICD and associated costs (cost of quality adjusted life years saved).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 4 Feb 2019
- Start date
- 23 Sept 2020
- Primary completion date
- Mar 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT03846297
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 23 Sept 2020 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
Other
- Specific etiologies such as amyloidosis
Who the study is looking for
- Patient with a diagnosis of HCM based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions
- Aged ≥ 16 years
- Patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention)
- Affiliation to a social security insurance
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré, Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.