Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Gr… (NCT03859466) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Austria63 participantsStarted 2018-11-16
Plain-language 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.
Who can participate
Age range
21 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
Timeframe: 360 days
2
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.