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

NCT ID: NCT03859466

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2023-03-15

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).

Conditions

Heart Failure Patients; Cardiac Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shockwave Therapy

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Holfeld, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria

Locations

Medical University of Innsbruck - Competence Center for Clinical Trials

Innsbruck, Tyrol, Austria

Countries

Austria

References

Nagele F, Polzl L, Graber M, Hirsch J, Mayr A, Pamminger M, Troger F, Theurl M, Schreinlechner M, Sappler N, Dorfmuller C, Mitrovic M, Ulmer H, 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-an update. Trials. 2022 Dec 9;23(1):988. doi: 10.1186/s13063-022-06931-4.

Reference Type: DERIVED

PMID: 36494706 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32473644 (View on PubMed)

Related Links

http://www.carelab.at

Cardiac Regeneration Research Lab

http://www.cast-trial.com

Trial Homepage

Other Identifiers

CIP-HEART-001

Identifier Type: -

Identifier Source: org_study_id