Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
|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.
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|