Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure - 02289

niversitaetsmedizin Goettingen0 个研究点目标入组 53 人开始时间: 2024年7月25日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Heart failure with reduced ejection fraction (HFrEF with EF = 35%) as assessed by high-resolution echocardiography and MRI or CT., At least one hypo- or dyskinetic segment to demark the implant target area., Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair, mechanical circulatory support device implantation) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index <16 mm (Rudski et al. 2010)., 18-80 years of age, Previous implantation of an ICD or CRT-D with event recorder, New York Heart Association (NYHA) Class III or IV under optimal medical therapy, Willingness and ability to give written informed consent, Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.

•Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1), Simultaneous participation in another interventional trial, Pregnant or breastfeeding females, Known or suspected alcohol and/or drug abuse, Contraindication to TachoSil® (e.g. hypersenstitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin- Hydrochloride), Hypertrophic cardiomyopathy (HCM), Terminal kidney failure (stage 4; GFR <30 ml/min) at the time of enrolment, Terminal liver failure (Child-Pugh stage C; score >10) at the time of enrolment, Autoimmune disease, History of disabling stroke, Reduced life expectancy in the short term due to non-cardiac disease, Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication)

发起方

niversitaetsmedizin Goettingen