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Trial record 3 of 3 for:    Tricvalve | Tricuspid Regurgitation

Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

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: NCT05114850
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
P+F Products + Features GmbH

Brief Summary:
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.

Condition or disease
Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Insufficiency Heart Failure Heart Diseases Heart Valve Diseases

Detailed Description:

The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.

The study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 450 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.
Actual Study Start Date : April 20, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2028



Primary Outcome Measures :
  1. Number of patients with readmission for HF [ Time Frame: up to 12 months ]
    First unplanned readmission for Heart Failure


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Number of patients in terms of all cause mortality

  2. Percentage of participants with major adverse events [ Time Frame: up to 12 months ]
    Percentage of participants with major adverse events

  3. Number of participants with severe adverse events [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Number of participants with severe adverse events

  4. Number of patients with readmission for HF [ Time Frame: up to 5 years ]
    First unplanned readmission for Heart Failure

  5. NYHA functional class [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Change of New York Heart Association (NYHA) functional class from III or IV to a lower one

  6. Change in BNP/NTproBNP and diuretic dosage [ Time Frame: up to 12 months ]
    Change in BNP/NTproBNP and diuretic dosage before intervention after intervention

  7. Change of the right atrium size [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Change of the Right Atrium Size assessed by echocardiography

  8. Change of the free valve movement [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Change of the free valve movement assessed by echocardiography

  9. Valve Device Regurgitation [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Number of patients with valve device regurgitation assessed by echocardiography

  10. Number of alive patients [ Time Frame: up to 30 days, up to 6 months, up to 5 years ]
    Number of alive patients free from reintervention related to TricValve System



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.
Criteria

Inclusion Criteria:

  • Successful treatment with TricValve Transcatheter Bicaval Valves System
  • Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent

Exclusion Criteria:

  • no exclusion criterion

Information from the National Library of Medicine

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): NCT05114850


Contacts
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Contact: Sandra Scheidl, MSc +436601148208 sscheidl@pfcardiovascular.com
Contact: Benjamin Reutterer, Dr +4369917237200 breutterer@pfcardiovascular.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
P+F Products + Features GmbH
Investigators
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Principal Investigator: Ignacio J Amat Santos, Dr Hospital Clínico Universitario de Valladolid
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Responsible Party: P+F Products + Features GmbH
ClinicalTrials.gov Identifier: NCT05114850    
Other Study ID Numbers: CTS-TRIC-003
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by P+F Products + Features GmbH:
Cardiovascular disease
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Tricuspid Valve Insufficiency
Cardiovascular Diseases