Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Zusammenfassung

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

Eignung

Studiendesign

Endpunkte

1. Primärer Endpunkt

   Freedom from device-related complications

   Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications

   Zeitrahmen 30 days after the index procedure

2. Primärer Endpunkt

   Reduction in Tricuspid Regurgitation Severity

   Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed

   Zeitrahmen 30 days after the index procedure

3. Sekundärer Endpunkt

   Tricuspid Valve Reintervention

   The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded

   Zeitrahmen 12 months after the index procedure

4. Sekundärer Endpunkt

   Permanent Pacemaker Implantation

   The number of participants who have received a permanent pacemaker implantation will be recorded

   Zeitrahmen 30 days after the index procedure

5. Sekundärer Endpunkt

   Combined all-cause mortality or rehospitalization for congestive heart failure

   The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded

   Zeitrahmen 12 months after the index procedure

6. Sekundärer Endpunkt

   All-cause mortality

   The number of deaths due to any cause will be recorded

   Zeitrahmen 12 months after the index procedure

7. Sekundärer Endpunkt

   Hospitalization for congestive heart failure

   The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded

   Zeitrahmen 12 months after the index procedure

8. Sekundärer Endpunkt

   The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure

   The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded. NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients

   Zeitrahmen 12 months after the index procedure

9. Sekundärer Endpunkt

   Device Thrombosis

   The number of participants who have been identified with device thrombosis will be recorded

   Zeitrahmen 12 months after the index procedure

10. Sekundärer Endpunkt

    Tricuspid Regurgitation Severity

    Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Higher mean scores are indicative of greater TR severity

    Zeitrahmen 12 months after the index procedure

11. Sekundärer Endpunkt

    Quality of Life - Kansas City Cardiomyopathy Questionnaire

    Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life

    Zeitrahmen 12 months after the index procedure

Daten

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

30 Studienzentren rekrutieren

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

1. 15. September 2026

   Abschlussdatum nach hinten verschoben

   Primary completion delayed 853 days

   2026-08-01 → 2028-12-01

2. 15. September 2026

   Studienzentrum hinzugefügt

   10 sites added (31 total)

   21 → 31