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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:
Participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.
This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy-related endpoints include patient-reported outcomes. | Change in:
| 360 days |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Holfeld, MD | University Hospital for Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck - Competence Center for Clinical Trials | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36494706 | Derived | 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. | |
| 32473644 |
| Label | URL |
|---|---|
| Cardiac Regeneration Research Lab | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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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
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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.
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| Secondary safety-related endpoints include patient-reported outcomes. |
|
| 6 Days |
| 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. |
| Trial Homepage | View source |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |