Back to resultsSafety and Performance of the Cardiovalve TR Replacement System (TARGET)
Primary Purpose
Tricuspid Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cardiovalve TR valve replacement System
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring Tricuspid valve, Heart valve, Cardiovascular disease
Eligibility Criteria
Inclusion Criteria:
- Functional TR ≥3+
- Symptomatic, NYHA Class II-IVa
- Patient approved by the Subject Screening Committee
Exclusion Criteria:
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- Hemodynamic instability
- Severe right ventricular failure
- Refractory heart failure requiring advanced intervention
Sites / Locations
- Universität BochumRecruiting
- Charité universityRecruiting
- Uniklinik BonnRecruiting
- Universitäres HerzRecruiting
- Herzzentrum UniklinikRecruiting
- University Heart Center LübeckRecruiting
- Universitätsklinikum - RegensburgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiovalve TR replacement Group
Arm Description
Cardiovalve TR valve replacement System
Outcomes
Primary Outcome Measures
Freedom from device or procedure-related adverse events
Freedom from device or procedure-related adverse events
Reduction in TR grade
Reduction in TR in comparison to baseline
Secondary Outcome Measures
Six minute walk test
Change in Six minute walk distance from Baseline
KCCQ
Change in health status from Baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05486832
Brief Title
Safety and Performance of the Cardiovalve TR Replacement System
Acronym
TARGET
Official Title
Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
August 15, 2026 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiovalve Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
Detailed Description
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
Tricuspid valve, Heart valve, Cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, single arm, open label, multi center
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiovalve TR replacement Group
Arm Type
Experimental
Arm Description
Cardiovalve TR valve replacement System
Intervention Type
Device
Intervention Name(s)
Cardiovalve TR valve replacement System
Intervention Description
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Primary Outcome Measure Information:
Title
Freedom from device or procedure-related adverse events
Description
Freedom from device or procedure-related adverse events
Time Frame
30 days
Title
Reduction in TR grade
Description
Reduction in TR in comparison to baseline
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Six minute walk test
Description
Change in Six minute walk distance from Baseline
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
KCCQ
Description
Change in health status from Baseline
Time Frame
30 days, 6 months, 12 months, annual for five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Functional TR ≥3+
Symptomatic, NYHA Class II-IVa
Patient approved by the Subject Screening Committee
Exclusion Criteria:
Cardiac anatomy deemed not suitable for the Cardiovalve TR system
Hemodynamic instability
Severe right ventricular failure
Refractory heart failure requiring advanced intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitza Shoham, PhD
Phone
+972546882988
Email
nitza@cardiovalve.com
Facility Information:
Facility Name
Universität Bochum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudolph Volker, MD
Facility Name
Charité university
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif Mohammad, MD
Facility Name
Uniklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Nickenig, MD
Facility Name
Universitäres Herz
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Schofer, MD
Facility Name
Herzzentrum Uniklinik
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Matti, MD
Facility Name
University Heart Center Lübeck
City
Lübeck
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian. Frerker, MD
Facility Name
Universitätsklinikum - Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Hilker, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Performance of the Cardiovalve TR Replacement System
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