Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

תקציר

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.

זכאות

תכנון המחקר

מדדי תוצאה

1. מדד תוצאה ראשוני

   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

   מסגרת זמן 30 days after the index procedure

2. מדד תוצאה ראשוני

   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

   מסגרת זמן 30 days after the index procedure

3. מדד תוצאה משני

   Tricuspid Valve Reintervention

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

   מסגרת זמן 12 months after the index procedure

4. מדד תוצאה משני

   Permanent Pacemaker Implantation

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

   מסגרת זמן 30 days after the index procedure

5. מדד תוצאה משני

   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

   מסגרת זמן 12 months after the index procedure

6. מדד תוצאה משני

   All-cause mortality

   The number of deaths due to any cause will be recorded

   מסגרת זמן 12 months after the index procedure

7. מדד תוצאה משני

   Hospitalization for congestive heart failure

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

   מסגרת זמן 12 months after the index procedure

8. מדד תוצאה משני

   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

   מסגרת זמן 12 months after the index procedure

9. מדד תוצאה משני

   Device Thrombosis

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

   מסגרת זמן 12 months after the index procedure

10. מדד תוצאה משני

    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

    מסגרת זמן 12 months after the index procedure

11. מדד תוצאה משני

    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

    מסגרת זמן 12 months after the index procedure

תאריכים

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

30 אתרים מגייסים

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

1. 15 בספטמבר 2026

   תאריך הסיום נדחה

   Primary completion delayed 853 days

   2026-08-01 → 2028-12-01

2. 15 בספטמבר 2026

   אתר נוסף

   10 sites added (31 total)

   21 → 31