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

Primary Purpose

Heart Failure Patients, Cardiac Ischemia

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Shockwave Therapy
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure Patients

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Innsbruck - Competence Center for Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Sham Control Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 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%
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.

Secondary Outcome Measures

Secondary efficacy-related endpoints include patient-reported outcomes.
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)
Secondary safety-related endpoints include patient-reported outcomes.
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

Full Information

First Posted
November 8, 2018
Last Updated
October 18, 2023
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT03859466
Brief Title
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Acronym
CAST-HF
Official Title
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Patients, Cardiac Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The masking is performed using opaque envelopes that are opened by an assistant at the end of the CABG procedure after the bypasses are fully established.
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm 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.
Arm Title
Sham Control Arm
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Shockwave Therapy
Intervention Description
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 Outcome Measure Information:
Title
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
Description
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%
Time Frame
360 days
Title
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
Description
The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.
Time Frame
360 days
Secondary Outcome Measure Information:
Title
Secondary efficacy-related endpoints include patient-reported outcomes.
Description
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)
Time Frame
360 days
Title
Secondary safety-related endpoints include patient-reported outcomes.
Description
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
Time Frame
6 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Holfeld, MD
Organizational Affiliation
University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Innsbruck - Competence Center for Clinical Trials
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
32473644
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.
Results Reference
derived
Links:
URL
http://www.carelab.at
Description
Cardiac Regeneration Research Lab
URL
http://www.cast-trial.com
Description
Trial Homepage

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

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