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NCT Number: NCT03859466

Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Heart Failure Patients Arterial Occlusive Diseases Arteriosclerosis Cardiac Ischemia Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Innsbruck - Competence Center for Clinical Trials

Innsbruck, Tyrol, 6020, Austria

About this study

This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shockwave therapy

Device

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.

Primary outcomes

  1. The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.

    Time frame: 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%

  2. The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.

    Time frame: 360 days

    The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.

Secondary outcomes

  1. Secondary efficacy-related endpoints include patient-reported outcomes.

    Time frame: 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)

  2. Secondary safety-related endpoints include patient-reported outcomes.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Acronym: CAST-HF

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Mar 1, 2019
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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