Klinische Studien

DEDICATE - DZHK6


Laufzeit: 01.04.2017 - 31.12.2024
Status: Rekrutierend
EudraCT-Nummer: NCT03112980
Nummer Ethikantrag: S-292/2017

Beschreibung der Studie

Die DEDICATE-DZHK6-Studie ist eine prospektive, randomisierte, multizentrische Studie. Sie vergleicht die kathetergestützte Therapie (Transkatheter-Aortenklappenimplantation, TAVI) mit der operativen Behandlung (chirurgischer Aortenklappenersatz, AKE) der hochgradigen Aortenklappenstenose bei 1.600 Patienten mit mittlerem bis niedrigem Operationsrisiko. Die Studie wird sowohl von den kardiologischen als auch herzchirurgischen Fachgesellschaften unterstützt und vom DZHK gefördert. Insgesamt nehmen 30 deutsche Herzzentren an der Studie teil.

 

Indikation/Einschlusskriterien

  1. Heart team consensus that TAVI and SAVR are both medically justified and advisable based on: a) Degenerative aortic valve stenosis with echocardiographically derived criteri  b) Patient is symptomatic from his/her aortic valve stenosis   c) Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE).  d) A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus.
  2. Patient has provided written informed consent to participate in the trial.
  3. Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures.
  4. The patient agrees to undergo SAVR, if randomized to control treatment.
  5. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
  6. Patients aged 70 to 85 years.
  7. Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause.

Ausschlusskriterien

  1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  2. Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus
  3. Previous cardiac surgery
  4. Any percutaneous coronary intervention performed within 1 month prior to the study procedure
  5. Untreated severe mitral or tricuspid regurgitation
  6. Untreated severe mitral stenosis
  7. Hemodynamic instability requiring inotropic support or mechanical circulatory support
  8. Ischemic stroke or intracranial bleeding within 1 month
  9. Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by resting echocardiogram
  10. Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient
  11. Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis
  12. Any other condition considered a contraindication for an isolated aortic valve procedure
  13. Symptomatic carotid or vertebral artery disease
  14. Expected life expectancy < 12 months due to associated non-cardiac comorbidities
  15. Currently participating in another investigational drug or device trial

Partner

Universitätsklinikum Hamburg-Eppendorf

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Förderung

Universitätsklinikum Hamburg-Eppendorf

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Personen

Portrait von Dr. med. Manuela Licka

Dr. med. Manuela Licka


Kontakt

Dr. med. Manuela Licka