Heart Disease
Conditions
Keywords
Chronic Ischemic Heart Disease
Brief summary
This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.
Interventions
PROCEDUREIntramyocardial Cell therapy
Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation
Sponsors
Kai Jaquet, PhD, DSc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* chronic left ventricular dysfunction (ejection fraction \<35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of \>15% of LVEF 3 months after CRT-device implantation * wall motion dysfunction of any territory * left bundle branch block * Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation
Exclusion criteria
* patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy * with relevant valvular disease; * Aneurysma of the anterior myocardial wall or myocardial wall thickness of \< 5 mm, * with overt heart failure, other than ischemic cardiomyopathy, * with history of stroke and/or transient ischemic attack (TIA), * with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system; * with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment; * with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease) * atrial fibrillation with average heart rate \>70 bpm * pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment; * with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results; * patients with a chronic or acute HIV-, HBV-, HCV-infection; * improvement of more than 15% of LVEF 3 months after CRT-device implantation * patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope. * patients who are currently participating in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVEF Value | 12 months | LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection |
Countries
Germany
Outcome results
None listed