Tricuspid RegurgitationNCT07334691
TARGET 2.0 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 1 site in Germany.
Trial summary
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. 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
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2026to Sep 2033
- 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
- Subject is ≥ 18 and <85 years
- Severe tricuspid regurgitation (TR) ≥3+ based upon echocardiography, as assessed by independent core laboratory using a 5-grade classification (mild (1), moderate (2), severe (3), massive (4), torrential (5)). Trace and no TR is considered 0)29
- Symptomatic, NYHA Class II-IV
- Left ventricular ejection fraction (LVEF) ≥ 30%
- Subject adequately treated based upon medical standards
- Subjects are at high risk for open heart surgery
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- Subject provided written, informed consent before investigation enrollment
- Subject approved by the Subject Screening Committee
- Anatomical Inclusion Criteria (measured by CT)
- Right femoral vein diameter > 9mm
- Tricuspid valve diameter < 55 mm
- RV length > 45 mm
Who cannot join
- Subjects will be excluded from the investigation if fulfill any of the following criteria:
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT)
- Venous peripheral anatomy or any spinal anatomy that is unsuitable for Cardiovalve TR implant delivery (by CT)
- Primary tricuspid disease that may interfere with Cardiovalve implantation
- Severe right ventricular failure (by Echo core lab adjudication)
- Significant coronary artery disease requiring percutaneous or surgical intervention
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- Severe systolic pulmonary arterial pressure, pASP > 2/3 systemic BP with PVR > 5 Wood units after vasodilator challenge
- Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
- Cerebrovascular event (stroke, TIA) within the past 3 months
- Active endocarditis or history of mitral/tricuspid endocarditis within 3 months or infection requiring antibiotic within 2 weeks before index procedure
- Subject has significant other sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, or aortic regurgitation or stenosis)
- Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
- Documented evidence of significant renal dysfunction (eGFR<30 ml/min/1.73m2) or any form of dialysis at time of screening within 30 days
- Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, contrast media, or Polyethylene Glycol (PEG)
- Subjects unsuitable for implantation due to thrombosis of the lower venous system or presence of a vena cava filter
- Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
- Liver cirrhosis > Child-Pugh Class A
- Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol
- Pregnant, lactating or planning pregnancy within next 12 months
- Requirement for antibiotic treatment within the last 48 hours
- Surgical or interventional procedure planned within 30 days prior to index procedure
- Refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) or UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
- Prior Tricuspid valve surgery or transcatheter tricuspid valve procedure that may interfere with the Cardiovalve device. Valve in a valve procedure is excluded.
- Modified Rankin Scale > 4 disability
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 30 days prior to index procedure
- Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope) at the time of screening
- Severe COPD or continuous use of home oxygen
- Hgb < 9 g/dL at screening
- The subject has contraindication against a transesophageal echo (TEE) during the procedure that cannot be replaced by other imaging.
- Currently participating in an investigational drug or another device investigation which has not reached its primary endpoint
- Subjects with >2 leads or with any lead that may interfere with Cardiovalve procedure or device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Uniklinik Bonn -
Bonn, 53127
Georg Nickenig
About this study
Official title: TARGET 2.0 Study: Safety and Performance of the Cardiovalve Tricuspid Valve Replacement System in the Treatment of Subjects With Tricuspid Regurgitation- Investigation
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.
Read the detailed description
"TARGET 2.0": Safety and Performance of the Cardiovalve Tricuspid valve replacement system in the treatment of subjects with tricuspid regurgitation- investigation: Cardiovalve Tricuspid Valve Replacement system (hereinafter referred to as Cardiovalve TR system) The system has not been granted CE mark at this time The Cardiovalve implant consists of three bovine pericardium tissue leaflets, self-expanding dual nitinol frame, and fabric. A total of 24 anchoring points affix the device to the native tricuspid annulus.
The Delivery System is intended to deliver the valve in the crimped position via the transfemoral venous approach. It comprises of a catheter assembly and handles. The handles knobs facilitate valve alignment and positioning in the native valve, and control the capsule expansion and release of the Cardiovalve implant.
The Cardiovalve TR Valve Replacement System is intended for reduction of tricuspid regurgitation (TR) in patients with symptomatic severe or greater secondary tricuspid regurgitation despite being treated with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team. The system percutaneously delivers the Implant to the tricuspid valve via femoral vein access This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Cardiovalve TR valve replacement System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovalve TR valve replacement SystemDevice
Cardiovalve Tricuspid Valve Replacement system
| Study group | Role | What they receive |
|---|---|---|
| Cardiovalve TR valve replacement System | Experimental | The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter. 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 posted12 Jan 2026
- Study start20 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2033 (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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovalve Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Nickenig, Principal investigator, Bonn Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334691
- Sponsor's protocol ID
- CP 25-01
- Status last verified
- May 2026
- First submitted
- 31 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
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 2.0 Study: Safety and Performance of the Cardiovalve Tricuspid Valve Replacement System in the Treatment of Subjects With Tricuspid Regurgitation- Investigation
- ClinicalTrials.gov ID
- NCT07334691
- Acronym / sponsor ID
- CP 25-01
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cardiovalve Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 12 Jan 2026 (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.
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.
Detailed description
"TARGET 2.0": Safety and Performance of the Cardiovalve Tricuspid valve replacement system in the treatment of subjects with tricuspid regurgitation- investigation: Cardiovalve Tricuspid Valve Replacement system (hereinafter referred to as Cardiovalve TR system) The system has not been granted CE mark at this time The Cardiovalve implant consists of three bovine pericardium tissue leaflets, self-expanding dual nitinol frame, and fabric. A total of 24 anchoring points affix the device to the native tricuspid annulus.
The Delivery System is intended to deliver the valve in the crimped position via the transfemoral venous approach. It comprises of a catheter assembly and handles. The handles knobs facilitate valve alignment and positioning in the native valve, and control the capsule expansion and release of the Cardiovalve implant.
The Cardiovalve TR Valve Replacement System is intended for reduction of tricuspid regurgitation (TR) in patients with symptomatic severe or greater secondary tricuspid regurgitation despite being treated with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team. The system percutaneously delivers the Implant to the tricuspid valve via femoral vein access This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovalve TR valve replacement System | Experimental | Device: Cardiovalve TR valve replacement SystemThe Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is ≥ 18 and <85 years
- Severe tricuspid regurgitation (TR) ≥3+ based upon echocardiography, as assessed by independent core laboratory using a 5-grade classification (mild (1), moderate (2), severe (3), massive (4), torrential (5)). Trace and no TR is considered 0)29
- Symptomatic, NYHA Class II-IV
- Left ventricular ejection fraction (LVEF) ≥ 30%
- Subject adequately treated based upon medical standards
Key exclusion criteria (31 listed)
- Subjects will be excluded from the investigation if fulfill any of the following criteria:
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT)
- Venous peripheral anatomy or any spinal anatomy that is unsuitable for Cardiovalve TR implant delivery (by CT)
- Primary tricuspid disease that may interfere with Cardiovalve implantation
- Severe right ventricular failure (by Echo core lab adjudication)
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 SystemCardiovalve Tricuspid Valve Replacement system | Device | Cardiovalve TR valve replacement System |
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.
- Individual participant dataSharing planned: No. No plan
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Not yet recruitingObservational study
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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.
Georg Nickenig principal investigator
Bonn Clinic
1 site 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 1 site 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 12 inclusion and 31 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: looking for participants now, 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 1 site 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?
Contact Dana Raveh Arbel (0528591891, danar@cardiovalve.com), or a site near the patient. 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.