Status:
COMPLETED
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Lead Sponsor:
Medical University Innsbruck
Conditions:
Heart Failure Patients
Cardiac Ischemia
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
This randomised, controlled clinical trial aims to evaluate the safety and efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring surgical revascularization...
Detailed 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).
Eligibility Criteria
Inclusion
- Inclusion criteria
- Male or female patients between 21 and 90 years of age undergoing primary coronary artery bypass grafting
- Presentation with reduced left ventricular function, defined as LVEF ≤ 40% measured by cardiac MRI
- Presentation with regional left ventricular wall motion abnormalities
- Written informed consent from the patient for participation in the study
- Exclusion criteria
- Significant concomitant aortic valve disease requiring surgical treatment (other than significant aortic valve disease not detected in preoperative cardiac ultrasound but detected during surgery)
- Serious radiographic contrast allergy
- Patient in cardiogenic shock or presenting with acute myocardial infarction (STEMI or NSTEMI)
- Patient with a contraindication for cardiac MRI
- History of significant ventricular arrhythmia, other than MI-associated arrhythmia
- Comorbidity reducing life expectancy to less than one year
- Presence of a ventricular thrombus
- Presence of a cardiac tumour
- Pregnancy
Exclusion
Key Trial Info
Start Date :
November 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03859466
Start Date
November 16 2018
End Date
March 15 2023
Last Update
October 19 2023
Active Locations (1)
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1
Medical University of Innsbruck - Competence Center for Clinical Trials
Innsbruck, Tyrol, Austria, 6020