Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
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|ClinicalTrials.gov Identifier: NCT01251185|
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Device: Cardiospec||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||December 2012|
Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.
Non-invasive, low-intensity extracoporeal shockwaves at energy density of 0.99 mJ/mm2. 9 treatment sessions, 20 minutes each, over a period of 9 weeks (3 sessions on weeks 1, 5 and 9).
- The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography. [ Time Frame: 6 months ]An echo examination shall be used to evaluate myocardial contractility post treatments.
- 6 Minutes Walk Test (6MWT) [ Time Frame: 6 months ]Evaluation of 6MWT time from baseline to 6 months post baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251185
|Tel Aviv Medical Center|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Hilton Miller, Professor||Tel Aviv Souraski Center|