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

October 18, 2023 updated by: Medical University Innsbruck

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medical University of Innsbruck - Competence Center for Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
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.
Device: Shockwave Therapy
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.
No Intervention: Sham Control Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
360 days
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.
360 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
360 days
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
6 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Johannes Holfeld, MD, University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2018

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-HEART-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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