Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    80
  • sponsor
    Medical University Innsbruck
Updated on 24 January 2021

Summary

Safety and Efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients undergoing coronary artery bypass grafting

Description

This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).

Details
Condition Heart Failure Patients
Treatment Shockwave therapy
Clinical Study IdentifierNCT03859466
SponsorMedical University Innsbruck
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 21 yrs and 90 yrs?
Gender: Male or Female
Do you have Heart Failure Patients?
Do you have any of these conditions: Do you have Heart Failure Patients??
Male or female patients above 21 and under 90 years of age undergoing primary coronary artery bypass grafting
Patients have to present with reduced left ventricular function defined as LVEF 40%
Patients have to present with regional left ventricular wall motion abnormalities
Patients have to give written informed consent to participate in the study

Exclusion Criteria

Significant concomitant valve disease in need of surgical treatment (Except significant valve disease not detected in preoperative cardiac ultrasound that is detected intra-operatively)
HIV positive patients
Hepatitis C positive patients
A baseline glomerular filtration rate <50 ml/min/1.73m2
Serious radiographic contrast allergy
Patients in cardiogenic shock
Patients with a contraindication for cardiac MRI
History of significant ventricular arrhythmias, except arrhythmias associated with MI
Present co-morbidity which reduces life expectancy to less than 1 year
Presence of ventricular thrombus
Presence of a cardiac tumor
Pregnancy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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