For professionals

To date no regenerative treatment of ischemic myocardium has been proven safe and effective for broad clinical use. Low-energy shockwave therapy has shown compelling effects in numerous clinical trials in orthopedic and traumatology indications. In a pilot trial on direct cardiac shockwave application in 10 human patients safety and feasibility could be proven.

The CAST Trial aims to show the beneficial effects of direct cardiac shockwave treatment adjunctive to coronary artery bypass graft surgery in patients suffering from reduced ejection fraction.

Study design

Prospective, randomized controlled, single-blind, monocenter

Sponsor of the Study

Medical University of Innsbruck

Number of patients

Max. 80 patients (interims analysis after 40 patients)

Duration of patient participation

360 days

Objectives

Primary

To assess the safety profile of the medical device (direct cardiac shockwave applicator)
To assess the improvement of LVEF by using cardiac shock wave therapy in patients undergoing primary coronary artery bypass grafting and suffering from reduced left ventricular function below or equal 40 %

Secondary

To assess the long-term safety profile of the medical device (direct cardiac shockwave applicator)
To assess the long-term performance profile of the medical device

Exploratory

To evaluate the potential association of genetic variants with disease characteristics and response to application of cardiac shockwave therapy

Inclusion criteria

Male or female patients above 21 and under 80 years of age undergoing primary coronary artery bypass grafting.
Patients have to present with reduced left ventricular function defined as LVEF ≤ 40%.
Patients have to present with regional left ventricular wall motion abnormalities.

Exclusion criteria

Significant concomitant valve disease in need of surgical treatment (Except significant valve disease not detected in preoperative cardiac ultrasound that is detected intra-operatively).
Serious radiographic contrast allergy.
Patients in cardiogenic shock.
Patients with a contraindication for cardiac MRI.
History of significant ventricular arrhythmias, except arrhythmias associated with MI.
Present co-morbidity which reduces life expectancy to less than 1 year.
Presence of ventricular thrombus.
Presence of a cardiac tumor.

Investigational Medical Device

Cardiac Shockwave Probe (CSP)

Manufacturer:

Heart Regeneration Technologies GmbH

A – 6020 Innsbruck, Kaiser Josef Straße 3