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

Not Applicable

Completed

• Conditions: Heart Failure Patients; Cardiac Ischemia
• Interventions: Device: Shockwave Therapy

• Registration Number: NCT03859466
• Lead Sponsor: Medical University Innsbruck

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).

Study Timeline

• Study First Submitted: 2018-11-08
• Study Start: 2018-11-16
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Primary Completion: 2022-06-01
• Status Verified: 2022-11
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Shockwave Therapy	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.

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.	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.	360 days	The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Innsbruck - Competence Center for Clinical Trials; 🇦🇹 Innsbruck, Tirol, Austria