Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Study Overview
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Brief Summary
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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.

Official Title
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Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: Transcatheter Tricuspid Valve Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing Transcatheter Tricuspid Valve Replacement Native Tricuspid Valve disease Orthotopic Tricuspid Valve Implantation Exclusion Criteria: Age under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement<br>Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement | Device: Transcatheter Tricuspid Valve Replacement<br>* All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days after the index procedure | 
| 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 | 30 days after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Permanent Pacemaker Implantation | The number of participants who have received a permanent pacemaker implantation will be recorded | 30 days after the index procedure | 
| 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 | 12 months after the index procedure | 
| All-cause mortality | The number of deaths due to any cause will be recorded | 12 months after the index procedure | 
| Hospitalization for congestive heart failure | The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded | 12 months after the index procedure | 
| 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 | 12 months after the index procedure | 
| Device Thrombosis | The number of participants who have been identified with device thrombosis will be recorded | 12 months after the index procedure | 
| 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 | 12 months after the index procedure | 
| 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 | 12 months after the index procedure | 
| Tricuspid Valve Reintervention | The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded | 12 months after the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valvular heart disease, tricuspid regurgitation, transcatheter tricuspid valve replacement