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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.

Study Description
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Brief Summary:
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: Cardiovalve TR valve replacement System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
Actual Study Start Date : December 9, 2022
Estimated Primary Completion Date : August 15, 2026
Estimated Study Completion Date : December 15, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cardiovalve TR replacement Group
Cardiovalve TR valve replacement System
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
    Freedom from device or procedure-related adverse events

  2. Reduction in TR grade [ Time Frame: 30 days ]
    Reduction in TR in comparison to baseline


Secondary Outcome Measures :
  1. Six minute walk test [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Change in Six minute walk distance from Baseline

  2. KCCQ [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Change in health status from Baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT05486832


Contacts
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Contact: Nitza Shoham, PhD +972546882988 nitza@cardiovalve.com

Locations
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Germany
Universität Bochum Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Rudolph Volker, MD         
Charité university Recruiting
Berlin, Germany, 10117
Contact: Sherif Mohammad, MD         
Uniklinik Bonn Recruiting
Bonn, Germany, 53127
Contact: Georg Nickenig, MD         
Universitäres Herz Recruiting
Hamburg, Germany, 20251
Contact: Niklas Schofer, MD         
Herzzentrum Uniklinik Recruiting
Köln, Germany, 50937
Contact: Adam Matti, MD         
University Heart Center Lübeck Recruiting
Lübeck, Germany, 20251
Contact: Christian. Frerker, MD         
Universitätsklinikum - Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Michael Hilker, MD         
Sponsors and Collaborators
Cardiovalve Ltd.
More Information
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Responsible Party: Cardiovalve Ltd.
ClinicalTrials.gov Identifier: NCT05486832    
Other Study ID Numbers: CP-21-01
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024

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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
Keywords provided by Cardiovalve Ltd.:
Tricuspid valve
Heart valve
Cardiovascular disease
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases