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Tricuspid RegurgitationTANDEM INCT05296148

A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

A study testing Transcatheter Tricuspid Valve Implantation in people with Tricuspid Regurgitation, run by CroiValve Limited at 3 sites in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe Tricuspid Regurgitation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Regurgitation
What is being tested?
Transcatheter Tricuspid Valve Implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesPoland
Study dates
17 Jun 2022to 31 Jul 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of severe Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE).
  • Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher)
  • Subject is on stable medical therapy as assessed by the Heart Team
  • The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee.
  • Age ≥18 years
  • The patient or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the EC of the respective clinical site.

Who cannot join

  • Subject is currently participating in another clinical investigation that could affect the outcome of this trial
  • Transesophageal echocardiography (TEE) is contraindicated or unsuccessful
  • Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention
  • Moderate to severe tricuspid valve stenosis
  • Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
  • Significant comorbid factors which places the subject at prohibitive risk for surgical repair in the judgment of the Investigational Site Heart Team and the Patient Screening Committee
Show all 36Show fewer
  • Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
  • Ejection Fraction (EF) <30% within 45 days of the implant procedure
  • Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation
  • Patient has Systolic Pulmonary Pressure (sPAP) >60 mm Hg
  • Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
  • Severe respiratory instability: Severe COPD or continuous use of home oxygen or has FEV1 <50% of predicted
  • Severe right ventricular dysfunction as determined by the Echo Core Lab
  • Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI
  • Stroke or transient ischemic event within 90 days prior to the implant procedure
  • Untreated severe symptomatic carotid stenosis (>70% by ultrasound)
  • Acute myocardial infarction within 30 days before the index procedure
  • Renal insufficiency (eGFR<25 ml/min)
  • Active endocarditis within 6 months of the implant procedure
  • Pulmonary embolism within the last 6 months
  • Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
  • Patient has an SVC dimension/anatomy is not suitable for device implantation (i.e., extremely tortuous, heavily calcified, aneurysmal)
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
  • Life expectancy <1 year
  • Active infections requiring current antibiotic therapy
  • Known severe liver disease
  • Prior heart or lung transplant
  • Known active peptic ulcer or active GI bleed
  • Unable to take anticoagulant therapy
  • Known patient is actively abusing drugs
  • Subjects who are pregnant or planning to become pregnant
  • Any condition making it unlikely the subject will be able to complete all protocol procedures (including compliance with guideline-directed medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result
  • Any known major coagulation abnormalities, thrombocytopenia, platelets <50,0000/ml or anemia Hb <9g/dl
  • Any known sensitivities or allergies to contrast and/or the device materials, including nickel and titanium
  • BMI >50kg/m2
  • Transvalvular implanted pacemaker or ICD lead is present

Trial locations and contacts

3 sites in 1 country.

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne GUMed

    Gdansk

  • Górnośląskie Centrum Medyczne im. Prof. Leszka Gieca

    Katowice

  • Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego

    Warsaw

Other trials in Poland

About this study

Official title: A European Feasibility Study of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe Tricuspid Regurgitation.

Being tested
Transcatheter Tricuspid Valve Implantation
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.

  • Transcatheter Tricuspid Valve ImplantationDevice

    Implantation of a tricuspid coaptation valve through a transcatheter approach.

Study groups in NCT05296148
Study groupRoleWhat they receive
TreatmentExperimentalTreatment with the CroíValve DUO Coaptation Valve System
Receives: Device: Transcatheter Tricuspid Valve Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from device or procedure related serious adverse events

    Freedom from device or procedure related serious adverse events

    Measured: Day 30

Secondary outcomes (3)

  1. Change in TR Grade

    Number of patients with reduction in TR from baseline as assessed by echocardiography

    Measured: Day 30, Month 6, Month 12

  2. NHYA Functional Class

    Number of patients with improvement in NYHA class

    Measured: Day 30, Month 6, Month 12

  3. Six Minute Walk Test (6MWT)

    Change in distance (m) from baseline

    Measured: Day 30, Month 6, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start17 Jun 2022
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05296148
Sponsor's protocol ID
CV005
Acronym
TANDEM I
Status last verified
Jul 2025
First submitted
7 Mar 2022
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Tricuspid Valve Implantation in people with Tricuspid Regurgitation, run by CroiValve Limited at 3 sites in Poland.

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 6 inclusion and 36 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland. 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 serious adverse events (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05296148.

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 31 Jul 2025.

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