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

This study has been completed.

Sponsor:

Collaborator:

Tel-Aviv Sourasky Medical Center

Information provided by (Responsible Party):

Medispec

ClinicalTrials.gov Identifier:

NCT01251185

First received: November 30, 2010

Last updated: February 17, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2010

Last Updated Date

February 17, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01251185 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Device: Cardiospec

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).

Other Names:

Cardiospec ESMR therapy
Extracorporeal Shockwave therapy
Extracorporeal myocardial Revascularization

Study Arm (s)

Experimental: CHF

Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.

Intervention: Device: Cardiospec

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient is male or female 18 years or older.
Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
Patient is classified as NYHA II to IV.
Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
Patients Ejection Fraction < 50%.
Patient is stable and without clinical events for > 3 months.
Patient has signed an informed consent form.
Patient's condition should be stable and should have a life expectancy of >12 months.
Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's)medical opinion.

Exclusion Criteria:

Patient with intraventricular thrombus.
Severe COPD (patients with an FEV1 less than .8 liters).
Patient has chronic lung disease including emphysema and pulmonary fibrosis.
Patient has active endocarditis, myocarditis or pericarditis.
Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
Patients who are unwilling or unable to cooperate with study procedure.
Patients who are unwilling to quit smoking during the study procedure (including screening phase).
Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
Patient is pregnant.
Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01251185

Other Study ID Numbers ^ICMJE

ESMR CHF-IL

Has Data Monitoring Committee

Responsible Party

Medispec

Study Sponsor ^ICMJE

Medispec

Collaborators ^ICMJE

Tel-Aviv Sourasky Medical Center

Investigators ^ICMJE

Principal Investigator:

Hilton Miller, Professor

Tel Aviv Souraski Center

Information Provided By

Medispec

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top