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Severe Tricuspid RegurgitationNCT03723239

TRICUS STUDY - Safety and Efficacy of the TricValve® Device

A study testing TricValve® System in people with Severe Tricuspid Regurgitation, run by P+F Products + Features GmbH at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Tricuspid Regurgitation
What is being tested?
TricValve® System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteLithuania
Study dates
12 Sep 2018to 15 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

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

  • The subject must be 18 years of age or older
  • The subject must be a patient with severe symptomatic tricuspid regurgitation demonstrated by echocardiography with significant backflow in the lower (IVC) and/or upper (SVC) vena cava and with a v-wave ≥ 25 mmHg as demonstrated by right heart catheterization (measured in the IVC and/or SVC 2-4 cm above/ below right atrium (RA) inflow) within 8 weeks prior to the implantation
  • Suitable for TricValve® Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography
  • The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV
  • The subject has left ventricular ejection fraction (LVEF) ≥ 40%
  • Distance covert in 6-minute walk test (6MWT) ≥ 60m
  • The patient shall be screened by a "Heart Team" - including an interventional cardiologist, cardiothoracic surgeon, and agreed as a candidate for the TricValve® Transcatheter Bicaval Valves System implantation
  • Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfil all of the expected requirements of the clinical protocol

Who cannot join

  • Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart teams decision
  • Requirement for other elective cardiac procedures e.g. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) up to 90 days after the procedure or 30 days before the procedure
  • Right ventricular failure (TAPSE ≤13mmHg)
  • Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography
  • Presence of any known life threatening (noncardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
  • Cerebro-vascular event within the past 3 months
Show all 19Show fewer
  • History of mitral/tricuspid endocarditis within the last 12 months
  • Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
  • Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
  • Documented evidence of significant renal dysfunction (serum creatinine > 3.0mg/dl) or on any form of dialysis at time of screening within the last 4 weeks
  • Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately premedicated
  • Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
  • The patient has contraindication against a transesophageal echo (TEE) during the procedure
  • Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
  • Liver cirrhosis Child C (see appendix)
  • Female patient of child-bearing potential
  • Psychiatric or behavioural disease including known alcohol or drug abuser that is likely to impair compliance with protocol
  • Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study
  • Requirement for Antibiotic Treatment within the last 48 hours

Trial locations and contacts

1 site in 1 country.

Lithuania1 site

  • LSMUH Kauno Kliniko

    Kaunas

Other trials in Lithuania

About this study

Official title: TRICUS STUDY - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation.

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

Read the detailed description

TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy.

Pre-Clinical and Clinical preliminary studies have shown an acceptable safety and performance profile of the TricValve® Transcatheter Bicaval Valves System. Given that the medical device is a potential long-term treatment for patients with tricuspid insufficiency, clinical data for long-term treatment periods is necessary. Thus, the current study is designed to investigate the safety and performance for at least 30 days and up to 6 months.

The study has been approved by the Kaunas Regional Biomedical Research Ethics Committee.

Being tested
TricValve® System
Keywords
Tricuspid Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
Medical subject headings
Tricuspid Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TricValve® SystemDevice

    The TricValve® Delivery System is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is unsheathed at the implantation site and positions itself as per the anatomy - self expanding frame.

Study groups in NCT03723239
Study groupRoleWhat they receive
TricValve® System Single-ArmExperimentalMinimally invasive catheter-supported, bicaval tricuspid valve (self-expanding) replacement
Receives: Device: TricValve® System

What is being measured

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

  1. Percentage of participants with major adverse events

    The percentage of participants with major adverse events (death, myocardial infarction, cardiac tamponade, cardiac surgery for failed TricValve® implantation, stroke. Major bleeding according to Valve Academic Research Consortium (VARC) criteria)

    Measured: 30 days

  2. Change of New York Heart Association (NYHA) functional class

    Change of New York Heart Association (NYHA) functional class from III or IV to a lower one

    Measured: 6 months

Secondary outcomes (7)

  1. Successful implantation

    The percentage of surviving participants with successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.

    Measured: Up to Discharge (≤ 10 days post index procedure)

  2. Unrestricted movement of cusps

    The percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography (nominal)

    Measured: Up to 30 days, up to 6 months

  3. Cusp insufficiency

    The change of the degree of cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value

    Measured: Up to 30 days, up to 6 months

  4. Device success

    Device success as measured by number of patients who are alive with intended device in place with no additional surgical or interventional procedures related to the TricValve®.

    Measured: Up to 30 days, up to 6 months

  5. NYHA functional class

    Number of Patients with improvement of NYHA functional class

    Measured: Up to 30 days

  6. 6 Minute Walk Test

    Improvement in distance (m) in the 6 Minute Walk Test

    Measured: Up to 30 days, up to 6 months

  7. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Number of Patients with improvement in quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ, a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Range of 0-100, in which higher scores reflect better health status.)

    Measured: Up to 30 days, up to 6 months

Timeline

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

  1. First posted29 Oct 2018
  2. Study start12 Sep 2018
  3. Primary completion4 Sep 2020
  4. Study completion15 Nov 2021

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03723239
Sponsor's protocol ID
CTP-TRIC-001
Status last verified
Apr 2022
First submitted
25 Oct 2018
Last updated
20 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blasco-Turrion S, Briedis K, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Sanchez-Luna JP, Gonzalez-Gutierrez JC, Revilla-Orodoea A, Zamorano JL, Gomez-Salvador I, Puri R, San Roman JA, Amat-Santos IJ. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv. 2024 Jan 8;17(1):60-72. doi: 10.1016/j.jcin.2023.10.043. Epub 2023 Dec 6.

    PubMed 38069986

Questions about this trial

What is this clinical trial studying?

A study testing TricValve® System in people with Severe Tricuspid Regurgitation, run by P+F Products + Features GmbH at 1 site in Lithuania.

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 8 inclusion and 19 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: finished, as of the sponsor's last update on 20 Apr 2022. 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 Lithuania. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of participants with major 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?

On the ClinicalTrials.gov record for NCT03723239, which also lists 1 linked publication.

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 20 Apr 2022.

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