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

Cardiac Ischemia Clinical Trial

— CAST-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859466
• Other study ID #: CIP-HEART-001
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: March 15, 2023

Study information

• Verified date: November 2022
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 15, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Ischemia
• Coronary Artery Disease
• Heart Failure Patients
• Ischemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck - Competence Center for Clinical Trials	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)	360 days
Secondary	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	6 Days

External Links

•   Cardiac Regeneration Research Lab
•   Trial Homepage