No registrations found.
ID
Source
Brief title
Health condition
ischemische cardiomyopathie, hartfalen
ischemic cardiomypathy, heart failure
Sponsors and support
Woermannkehre 1
D - 12359 Berlin
Germany
0049 (0)30 689-050
Woermannkehre 1
D - 12359 Berlin
Germany
0049 (0)30 689-050
Intervention
Outcome measures
Primary outcome
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
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).
Background summary
In the present clinical investigation, we will perform an analysis of baseline risk factors to identify predictors for appropriate ICD intervention in patients with ischemic cardiomyopathy receiving an ICD for primary prevention. The study will be performed in centres in The Netherlands.
Study objective
The primary alternative hypothesis states that the mean relative infarct transmurality (RIT) is different in patients with (RITshock or ATP ) and without appropriate ICD intervention, i.e. shock or ATP.
Study design
Patients will be seen by the investigator at the enrolment visit, pre implant screening, ICD implantation, pre-hospital discharge
visit, and follow-up (FUP) visits at 2, 6, 12, 18, 24 months including home monitoring. Additional routine FUP every 6 months until study termination after last enrolled patient has completed 2 years FUP.
Intervention
ICD implantation. Patients are alreay planned for ICD. So they will also receive an ICD when they are not participating in the study.
Medialaan 36
Mark Ver Heyen
Vilvoorde B-1800
Belgium
0032 499 534 826
m.verheyen@biotronik.be
Medialaan 36
Mark Ver Heyen
Vilvoorde B-1800
Belgium
0032 499 534 826
m.verheyen@biotronik.be
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;
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 <18 years and >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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3131 |
| NTR-old | NTR3331 |
| Other | METC : 11.10115 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |