Clinical trial NCT03859466: Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Official title: Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Patients
Cardiac Ischemia
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
timeFrame: 360 days
measure: The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
timeFrame: 360 days
Secondary outcomes:
measure: Secondary efficacy-related endpoints include patient-reported outcomes.
timeFrame: 360 days
measure: Secondary safety-related endpoints include patient-reported outcomes.
timeFrame: 6 Days
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck - Competence Center for Clinical Trials
state: Tirol
Study officials:
affiliation: University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
name: Johannes Holfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polzl L, Nagele F, Graber M, Hirsch J, Lobenwein D, Mitrovic M, Mayr A, Theurl M, Schreinlechner M, Pamminger M, Dorfmuller C, Grimm M, Gollmann-Tepekoylu C, Holfeld J. Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial. Trials. 2020 May 30;21(1):447. doi: 10.1186/s13063-020-04369-0.