Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting (CAST-HF)

Medical University Innsbruck

Status: Completed

Conditions: Cardiac Ischemia; Heart Failure Patients

Treatments: Device: Shockwave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03859466

CIP-HEART-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 63 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

In the intervention arm, 300 shockwave impulses per coronary supply territory, at an energy flux density of 0.38mJ/mm2 and a frequency 3Hz, are applied in direct contact with the ischaemic myocardium of the left ventricle. The intervention is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass.

Treatment:

Device: Shockwave Therapy

Sham Control Arm

No Intervention group

Description:

In the sham control arm, the same manipulations are performed with an inactive shockwave applicator in direct contact with the ischaemic myocardium of the left ventricle as in the intervention arm. The sham treatment is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass.