Tricuspid RegurgitationTARGETNCT05486832
TARGET Study: Safety and Performance of the Cardiovalve TR Replacement System
A study testing Cardiovalve TR valve replacement System in people with Tricuspid Regurgitation, run by Cardiovalve Ltd. at 7 sites in Germany.
Trial summary
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Cardiovalve TR valve replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 7 sitesGermany
- Study dates
- 9 Dec 2022to 15 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional TR ≥3+
- Symptomatic, NYHA Class II-IVa
- Patient approved by the Subject Screening Committee
Who cannot join
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- Hemodynamic instability
- Severe right ventricular failure
- Refractory heart failure requiring advanced intervention
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Universität Bochum
Bad Oeynhausen, 32545
Charité university
Berlin, 10117
Uniklinik Bonn
Bonn, 53127
Herzzentrum Uniklinik
Cologne, 50937
Universitäres Herz
Hamburg, 20251
University Heart Center Lübeck
Lübeck, 20251
Universitätsklinikum - Regensburg
Regensburg, 93053
About this study
Official title: TARGET Study: Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
Read the 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
- Conditions
- Tricuspid Regurgitation
- Being tested
- Cardiovalve TR valve replacement System
- Keywords
- Tricuspid valve, Heart valve, Cardiovascular disease
- Medical subject headings
- Tricuspid Valve Insufficiency, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovalve TR valve replacement SystemDevice
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovalve TR replacement Group | Experimental | Cardiovalve TR valve replacement System Receives: Device: Cardiovalve TR valve replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device or procedure-related adverse events
Freedom from device or procedure-related adverse events
Measured: 30 days
Reduction in TR grade
Reduction in TR in comparison to baseline
Measured: 30 days
Secondary outcomes (2)
Six minute walk test
Change in Six minute walk distance from Baseline
Measured: 30 days, 6 months, 12 months, annual for five years
KCCQ
Change in health status from Baseline
Measured: 30 days, 6 months, 12 months, annual for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start9 Dec 2022
- Primary completion15 Mar 2026
- Study completion15 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single arm, open label, multi center
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovalve Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Nickenig, Dr, Principal investigator, Bonn Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486832
- Sponsor's protocol ID
- CP 21-01
- Acronym
- TARGET
- Status last verified
- May 2026
- First submitted
- 2 Aug 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGET Study: Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT05486832
- Acronym / sponsor ID
- TARGET / CP 21-01
- Conditions
- Tricuspid Regurgitation
- Keywords
- Tricuspid valve, Heart valve, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Cardiovalve Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Dec 2031 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single arm, open label, multi center
| Arm | Type | Receives |
|---|---|---|
| Cardiovalve TR replacement Group | Experimental | Device: Cardiovalve TR valve replacement SystemCardiovalve TR valve replacement System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Functional TR ≥3+
- Symptomatic, NYHA Class II-IVa
- Patient approved by the Subject Screening Committee
Key exclusion criteria (4 listed)
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- Hemodynamic instability
- Severe right ventricular failure
- Refractory heart failure requiring advanced intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovalve TR valve replacement SystemThe Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter. | Device | Cardiovalve TR replacement Group |
Primary outcome
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
2 secondary outcomes
Six minute walk test
Time frame: 30 days, 6 months, 12 months, annual for five years
KCCQ
Time frame: 30 days, 6 months, 12 months, annual for five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Nickenig, Dr principal investigator
Bonn Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovalve TR valve replacement System in people with Tricuspid Regurgitation, run by Cardiovalve Ltd. at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device or procedure-related adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.