Prospective Assessment of Risk Factors for Appropriate ICD Intervention in Patients with Ischemic Cardiomyopathy.
Completed
- Conditions
- ischemische cardiomyopathie, hartfalenischemic cardiomypathy, heart failure
- Registration Number
- NL-OMON20942
- Lead Sponsor
- BIOTRONIK SE & Co. KGWoermannkehre 1D - 12359 BerlinGermany0049 (0)30 689-050
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Patient with ischemic cardiomyopathy indicated for a de novo ICD implantation for primary prevention, according to ESC guidelines or local standards (MADIT II population);
2. Written informed consent / willingness and ability to comply with the protocol.
Exclusion Criteria
1. Contraindication for MRI;
2. Severe renal dysfunction (stage 4 or 5) resulting in contra-indication for the admission of gadolinium during MRI;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the clinical investigation is to determine whether there is a relationship between appropriate ICD intervention (shock or ATP) and the Relative Infarct Transmurality (RIT) obtained from Late Gadolinium Enhanced Cardiac Magnetic Resonance (LGE-CMR) imaging in patients with ischemic cardiomyopathy, receiving an ICD for primary prevention (MADIT II population).
- Secondary Outcome Measures
Name Time Method The secondary objectives of the clinical investigation are to identify baseline risk factors for appropriate ICD intervention determined before ICD implantation and to provide sufficient clinical data for a future confirmatory clinical investigation:<br /><br>1. Identify a RIT cut-off value as a baseline risk factor that can predict appropriate ICD intervention;<br /><br>2. Identify other baseline risk factors that can predict appropriate ICD intervention;<br /><br>3. Design a risk score system, based on risk factors in Coumel categories including trigger (PVC/hr), modulation (HRV) and substrate (RIT).