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

NCT01251185 | Completed Phase 1

• 1 other identifier: ESMR CHF-IL
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Extracorporeal Shockwave Therapy; Heart Failure; Congestive Heart Failure; Non-invasive; Device Trial; NYHA (New York Heart Association); Ischemic cardiomyopathy; Ischemia; Myocardial contractility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 6 Minutes Walk Test (6MWT)

  6 months

Study Arms (1)

CHF

EXPERIMENTAL

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

Device: Cardiospec

Interventions

Cardiospec DEVICE

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).

Also known as: Cardiospec ESMR therapy, Extracorporeal Shockwave therapy, Extracorporeal myocardial Revascularization

CHF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medispec: lead
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Heart Failure; Ischemia

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hilton Miller, Professor

  Tel Aviv Souraski Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

IL (1)