Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractory Angina Pectoris Ischemic Heart Disease Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Shockwave Therapy

Patients in this group receive shockwave therapy.

Group Type EXPERIMENTAL

Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

Intervention Type DEVICE

40 - 60 spots per visit (200 shots/spot) at Energy Level 3

Interventions

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Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

40 - 60 spots per visit (200 shots/spot) at Energy Level 3

Intervention Type DEVICE

Other Intervention Names

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Modulith SLC Extracorporeal Cardiac Shockwave Therapy (CSWT)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No