Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
This study has been completed.
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
First received: November 30, 2010
Last updated: February 17, 2013
Last verified: February 2013
Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.|
Resource links provided by NLM:
Further study details as provided by Medispec:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]An echo examination shall be used to evaluate myocardial contractility post treatments.
Secondary Outcome Measures:
- 6 Minutes Walk Test (6MWT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation of 6MWT time from baseline to 6 months post baseline.
|Study Start Date:||January 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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).
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