Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
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| ClinicalTrials.gov Identifier: NCT05114850 |
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Recruitment Status :
Recruiting
First Posted : November 10, 2021
Last Update Posted : January 27, 2023
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| Condition or disease |
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| Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Insufficiency Heart Failure Heart Diseases Heart Valve Diseases |
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.
| 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 |
- Number of patients with readmission for HF [ Time Frame: up to 12 months ]First unplanned readmission for Heart Failure
- 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
- Percentage of participants with major adverse events [ Time Frame: up to 12 months ]Percentage of participants with major adverse events
- 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
- Number of patients with readmission for HF [ Time Frame: up to 5 years ]First unplanned readmission for Heart Failure
- 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
- Change in BNP/NTproBNP and diuretic dosage [ Time Frame: up to 12 months ]Change in BNP/NTproBNP and diuretic dosage before intervention after intervention
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
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
| Contact: Sandra Scheidl, MSc | +436601148208 | sscheidl@pfcardiovascular.com | |
| Contact: Benjamin Reutterer, Dr | +4369917237200 | breutterer@pfcardiovascular.com |
Show 28 study locations
| Principal Investigator: | Ignacio J Amat Santos, Dr | Hospital Clínico Universitario de Valladolid |
| 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: | January 27, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cardiovascular disease |
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Heart Diseases Tricuspid Valve Insufficiency Heart Valve Diseases Cardiovascular Diseases |