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. The main questions to answer are: * Does cardiac shockwave therapy, in addition to CABG surgery, improve left ventricular ejection fraction? * Is cardiac shockwave therapy in addition to CAGB surgery safe? Participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.
This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
The cardiac shockwave system consists of a table-top device (Nonvasiv Medical GmbH, Konstanz, Germany) and a sterile single-use applicator releasing electrohydraulic shockwaves (Heart Regeneration Technologies GmbH, Innsbruck, Austria). Prior to use, the applicator is inserted into a sterile cover containing ultrasound gel. In order to ensure acoustic coupling between the applicator and the myocardium, continuous saline rinsing is applied throughout the procedure.
Medical University of Innsbruck - Competence Center for Clinical Trials
Innsbruck, Tyrol, Austria
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
The primary efficacy objective is to assess the efficacy of cardiac shock wave therapy in patients undergoing primary coronary artery bypass grafting and suffering from reduced left ventricular function ≤ 40%
Time frame: 360 days
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.
Time frame: 360 days
Secondary efficacy-related endpoints include patient-reported outcomes.
Change in: * 6- Minute Walk Test Distance * NYHA functional class * Serum nt-proBNP levels * Renal function (GFR) * Seattle Angina Pectoris Questionnaire (SAQ) * 36-item short-form survey (SF36) * Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 360 days
Secondary safety-related endpoints include patient-reported outcomes.
* Occurance of ventricular arrhythmia during hospital stay * Occurrence of device-related peri-operative myocardial damage detected by rise of cardiac biomarkers (CK-MB, TropT) Occurrence of signs of device-related infection (CRP, leucocytosis) during hospital stay
Time frame: 6 Days
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