Prospective Assessment of Risk Factors for Appropriate ICD Intervention in Patients with Ischemic Cardiomyopathy.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20942

Enrollment

200

Registered

2012-03-05

Start date

2012-04-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemische cardiomyopathie, hartfalen ischemic cardiomypathy, heart failure

Interventions

ICD implantation. Patients are alreay planned for ICD. So they will also receive an ICD when they are not participating in the study.

Eligibility

Inclusion criteria

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

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; 3. Indication for secondary prevention ICD implantation; 4. Class I indication for cardiac resynchronization therapy; 5. Heart failure with New York Heart Association functional class IV; 6. LV ejection fraction >40%; 7. Age 85 years; 8. Women that are pregnant, lactating or planning to become pregnant; 9. Participating in any other clinical trial with active intervention(s) during the course of this study; 10. Life expectancy less than 1 year.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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: 1. Identify a RIT cut-off value as a baseline risk factor that can predict appropriate ICD intervention; 2. Identify other baseline risk factors that can predict appropriate ICD intervention; 3. Design a risk score system, based on risk factors in Coumel categories including trigger (PVC/hr), modulation (HRV) and substrate (RIT).	—

Measure

Time frame

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: 1. Identify a RIT cut-off value as a baseline risk factor that can predict appropriate ICD intervention; 2. Identify other baseline risk factors that can predict appropriate ICD intervention; 3. Design a risk score system, based on risk factors in Coumel categories including trigger (PVC/hr), modulation (HRV) and substrate (RIT).

—

Contacts

Public ContactMark Ver Heyen

BIOTRONIK Belgium Medialaan 36

m.verheyen@biotronik.be0032 499 534 826

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)