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Trial record 1 of 6 for:    cardiovalve
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Safety and Performance of the Cardiovalve TR Replacement System (TARGET)

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: NCT05486832
Recruitment Status : Recruiting
First Posted : August 4, 2022
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Cardiovalve Ltd.

Tracking Information
First Submitted Date  ICMJE August 2, 2022
First Posted Date  ICMJE August 4, 2022
Last Update Posted Date February 7, 2024
Actual Study Start Date  ICMJE December 9, 2022
Estimated Primary Completion Date August 15, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2022)
  • Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
    Freedom from device or procedure-related adverse events
  • Reduction in TR grade [ Time Frame: 30 days ]
    Reduction in TR in comparison to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2022)
  • Six minute walk test [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Change in Six minute walk distance from Baseline
  • KCCQ [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Change in health status from Baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Performance of the Cardiovalve TR Replacement System
Official Title  ICMJE Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
prospective, single arm, open label, multi center
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Regurgitation
Intervention  ICMJE Device: Cardiovalve TR valve replacement System
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Study Arms  ICMJE Experimental: Cardiovalve TR replacement Group
Cardiovalve TR valve replacement System
Intervention: Device: Cardiovalve TR valve replacement System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2022)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2026
Estimated Primary Completion Date August 15, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nitza Shoham, PhD +972546882988 nitza@cardiovalve.com
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05486832
Other Study ID Numbers  ICMJE CP-21-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cardiovalve Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cardiovalve Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cardiovalve Ltd.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP