Cardiac Ischemia, Heart Failure Patients
Conditions
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. 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.
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).
Interventions
DEVICEShockwave Therapy
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.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The masking is performed using opaque envelopes that are opened by an assistant at the end of the CABG procedure after the bypasses are fully established.
Intervention model 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) vs. Sham treatment
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days. | 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% |
| The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days. | 360 days | The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy-related endpoints include patient-reported outcomes. | 360 days | 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) |
| Secondary safety-related endpoints include patient-reported outcomes. | 6 Days | * 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 |
Countries
Austria
Outcome results
None listed