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Completed

NCT Number: NCT01251185

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Other names: Cardiospec ESMR therapy, Extracorporeal Shockwave therapy, Extracorporeal myocardial Revascularization

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.

    Time frame: 6 months

    An echo examination shall be used to evaluate myocardial contractility post treatments.

Secondary outcomes

  1. 6 Minutes Walk Test (6MWT)

    Time frame: 6 months

    Evaluation of 6MWT time from baseline to 6 months post baseline.

Sponsors and collaborators

Lead sponsor

Medispec

Industry

Collaborators

  • Tel-Aviv Sourasky Medical Center

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2010
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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