Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Storz Medical

Status: Withdrawn

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Refractory Angina Pectoris

Treatments: Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03438500

CSW-1814-SCH-0010-S

Details and patient eligibility

About

The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

Full description

This is a mono-center, prospective, single arm, pilot study designed to assess the feasibility of the "Cardiac Shock Wave Treatment" in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

A total of 10 subjects will be enrolled in the study. All enrolled study subjects will be assessed for clinical follow-up at the following intervals: 5 and 14 weeks post CSWT procedure.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of anginal chest pain that prompted a myocardial stress test (nuclear myocardial perfusion imaging, stress echocardiography, or perfusion CMR)
• Evidence for stress-induced myocardial ischemia in this examination
• Coronary angiogram showing absence of ≥30% stenosis of epicardial coronary arteries

Exclusion criteria

• Participation in other clinical trials
• age <18 years
• Contraindications to under cMRI
• Contraindications to adenosine (severe chronic obstructive pulmonary disease (COPD), asthma, atrioventricular block (AV block) > grade 1)
• Left ventricular thrombus
• Uncontrolled diabetes mellitus
• Uncontrolled arterial hypertension,
• Any other severe chronic illness such as liver or renal failure (glomerular filtration rate (GFR) < 45 ml/min), active neoplastic disease, history of myocardial infarction or coronary revascularization within the past three months
• Patients with pacemaker or implanted cardioverter defibrillator
• Patients after valve surgical replacement
• Patients after interventional valve replacement or reconstruction (e.g. transfemoral aortic valve replacement or MitraClip implantation)
• Pregnancy (a reliable method of contraception must be used for the entire duration of the study)
• Fertile female participants who are capable of bearing children and who do not use a method of contraception that is medically approved by the health authority of the respective country
• Missing capacity to consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Active Shockwave Therapy

Experimental group

Description:

Patients in this group receive shockwave therapy.

Treatment:

Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)