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

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

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

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: Cardiospec

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is male or female 18 years or older.
2. Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
3. Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
4. Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
5. Patient is classified as NYHA II to IV.
6. Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
7. Patients Ejection Fraction < 50%.
8. Patient is stable and without clinical events for > 3 months.
9. Patient has signed an informed consent form.
10. Patient's condition should be stable and should have a life expectancy of >12 months.
11. 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:

1. Patient with intraventricular thrombus.
2. Severe COPD (patients with an FEV1 less than .8 liters).
3. Patient has chronic lung disease including emphysema and pulmonary fibrosis.
4. Patient has active endocarditis, myocarditis or pericarditis.
5. 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.
6. Patients who are unwilling or unable to cooperate with study procedure.
7. Patients who are unwilling to quit smoking during the study procedure (including screening phase).
8. Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
9. Patient is pregnant.
10. Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF; Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	An echo examination shall be used to evaluate myocardial contractility post treatments.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minutes Walk Test (6MWT)	Evaluation of 6MWT time from baseline to 6 months post baseline.	6 months

Collaborators and Investigators

• Sponsor: Medispec
• Collaborators: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Hilton Miller, Professor, Tel Aviv Souraski Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 1, 2010

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 17, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Heart Failure; Ischemia; Congestive Heart Failure; Non-invasive; Ischemic cardiomyopathy; Extracorporeal Shockwave Therapy; Device Trial; NYHA (New York Heart Association); Myocardial contractility
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ESMR CHF-IL