Status:
TERMINATED
Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy
Lead Sponsor:
Kai Jaquet, PhD, DSc
Conditions:
Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01144221
Start Date
May 1 2010
End Date
February 1 2015
Last Update
April 9 2018
Active Locations (1)
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1
Asklepios Clinic St. Georg
Hamburg, Germany, 20099