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Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting (CAST-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859466
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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Brief Summary:
Safety and Efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients undergoing coronary artery bypass grafting

Condition or disease Intervention/treatment Phase
Heart Failure Patients Device: Shockwave Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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) vs. Placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Arm
For each of this packages exactly half of the envelops will be filled with control (20/40) or intervention (20/40) information: This is a prospective, single-blind, randomized, single-centre study. The investigational medicinal product (shockwave therapy) to which individual patients will be assigned is determined by a randomised schedule with a 1:1 allocation ratio
 Device: Shockwave Therapy

Surgically invasive device, transient use only for the time of surgical intervention, intended for use in direct contact with the heart, intended to correct defect of the heart.

Throughout the study, investigators are permitted to use their clinical judgement when prescribing concomitant medications and treatments for trial patients. Local prescribing information and institutional guidelines should be followed as applicable
No Intervention: Control Arm
For each of this packages exactly half of the envelops will be filled with control (20/40) or intervention (20/40) information This is a prospective, single-blind, randomized, single-centre study. The investigational medicinal product (shockwave therapy) to which individual patients will be assigned is determined by a randomised schedule with a 1:1 allocation ratio


Outcome Measures
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Primary Outcome Measures :
  1. Number of related adverse events (Safety) and differences in LVEF (Efficacy) with in one week [ Time Frame: 7 days ]
    To assess the safety profile of the device (number of related adverse events, control vs. treatment group) To assess the Improvement of LVEF after treatment (control vs. treatment group)


Secondary Outcome Measures :
  1. Number of related adverse events (Safety) and differences in LVEF (Efficacy) with in one year [ Time Frame: 360 days ]
    To assess the safety profile of the device (number of related adverse events, control vs. treatment group over a period of 1 year) To assess the Improvement of LVEF after treatment (control vs. treatment group over a period of 1 year)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female patients above 21 and under 90 years of age undergoing primary coronary artery bypass grafting.
  • Patients have to present with reduced left ventricular function defined as LVEF ≤ 40%.
  • Patients have to present with regional left ventricular wall motion abnormalities.
  • Patients have to give written informed consent to participate in the study.

Exclusion Criteria:

  • Significant concomitant valve disease in need of surgical treatment (Except significant valve disease not detected in preoperative cardiac ultrasound that is detected intra-operatively).
  • HIV positive patients
  • Hepatitis C positive patients
  • A baseline glomerular filtration rate <50 ml/min/1.73m2
  • Serious radiographic contrast allergy.
  • Patients in cardiogenic shock.
  • Patients with a contraindication for cardiac MRI.
  • History of significant ventricular arrhythmias, except arrhythmias associated with MI.
  • Present co-morbidity which reduces life expectancy to less than 1 year.
  • Presence of ventricular thrombus
  • Presence of a cardiac tumor
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859466


Contacts
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Contact: Johannes Holfeld +43 0512 504 80800 johannes.holfeld@i-med.ac.at
Contact: Can Gollmann-Tepeköylü +43 0512 504 80466 can.gollmann-tepekoeylue@tirol-kliniken.at

Locations
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Austria
Medical University of Innsbruck - Competence Center for Clinical Trials Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Nihad Muric    +43 0512 9003 70085    nihad.muric@i-med.ac.at   
Contact: Sabine Embacher-Aichhorn    +43 0512 9003 70085    sabine.embacher@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03859466    
Other Study ID Numbers: CIP-HEART-001
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases