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.
ID
Bron
Verkorte titel
Aandoening
ischemische cardiomyopathie, hartfalen
ischemic cardiomypathy, heart failure
Ondersteuning
Woermannkehre 1
D - 12359 Berlin
Germany
0049 (0)30 689-050
Woermannkehre 1
D - 12359 Berlin
Germany
0049 (0)30 689-050
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
ICD implantation. Patients are alreay planned for ICD. So they will also receive an ICD when they are not participating in the study.
Publiek
Medialaan 36
Mark Ver Heyen
Vilvoorde B-1800
Belgium
0032 499 534 826
m.verheyen@biotronik.be
Wetenschappelijk
Medialaan 36
Mark Ver Heyen
Vilvoorde B-1800
Belgium
0032 499 534 826
m.verheyen@biotronik.be
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3131 |
| NTR-old | NTR3331 |
| Ander register | METC : 11.10115 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |