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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tricuspid Regurgitation | Device: Cardiovalve TR valve replacement System | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Cardiovalve TR replacement Group
Cardiovalve TR valve replacement System
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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. |
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Nitza Shoham, PhD | +972546882988 | nitza@cardiovalve.com |
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 |
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 |
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 |
Tricuspid valve Heart valve Cardiovascular disease |
Tricuspid Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |