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

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03859466
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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. PlaceboThis 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: Nov 16, 2018
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm For each of this packages exactly half of the envelops will be filled with control (20/20) or intervention (20/20) 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 (20/20) or intervention (20/20) 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

Primary Outcome Measures

1. Number of related adverse events (Safety) and differences in LVEF (Efficacy) with in one week [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 [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

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 or presentig with acute myocardial infarction (STEMI or NSTEMI)

• 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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Innsbruck - Competence Center for Clinical Trials	Innsbruck	Tirol	Austria	6020

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT03859466
• Other Study ID Numbers: CIP-HEART-001
• First Posted: Mar 1, 2019
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

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

Study Results

No Results Posted as of Jul 12, 2022