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

NCT03859466 | Completed DMC

• 1 other identifier: CIP-HEART-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure Patients; Cardiac Ischemia

Outcome Measures

Primary Outcomes (2)

• 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%

  360 days

• 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.

  360 days

Secondary Outcomes (2)

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

  360 days

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

  6 Days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Sham Control Arm

NO INTERVENTION

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.

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck - Competence Center for Clinical Trials

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (2)

• 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.

  PMID: 36494706 DERIVED

• 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.

  PMID: 32473644 DERIVED

Related Links

• Cardiac Regeneration Research Lab
• Trial Homepage

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Johannes Holfeld, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: March 1, 2019
• Study Start: November 16, 2018
• Primary Completion: June 1, 2022
• Study Completion: March 15, 2023
• Last Updated: October 19, 2023

Record last verified: 2022-11

Locations

AU (1)