Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

• Conditions: Tricuspid Regurgitation
• Interventions: Device: Transcatheter Tricuspid Valve Replacement

• Registration Number: NCT06033274
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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.

Detailed Description

The primary aims of the registry will be:

* To examine the safety, efficacy, and long-term outcomes of TTVR

* To assess the incidence of procedural complications and their correlations with adverse clinical outcomes

* To investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after TTVR

* To explore the characteristics of patients deemed eligible for TTVR.

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Study Start: 2023-10-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients undergoing Transcatheter Tricuspid Valve Replacement
• Native Tricuspid Valve disease
• Orthotopic Tricuspid Valve Implantation

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Exclusion Criteria

• Age under 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement	Transcatheter Tricuspid Valve Replacement	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

Primary Outcome Measures

Name	Time	Method
Freedom from device-related complications	30 days after the index procedure	Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
Reduction in Tricuspid Regurgitation Severity	30 days after the index procedure	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

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	12 months after the index procedure	The number of deaths due to any cause will be recorded
Hospitalization for congestive heart failure	12 months after the index procedure	The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded
Tricuspid Valve Reintervention	12 months after the index procedure	The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded
Combined all-cause mortality or rehospitalization for congestive heart failure	12 months after the index procedure	The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded
The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure	12 months after the index procedure	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
Permanent Pacemaker Implantation	30 days after the index procedure	The number of participants who have received a permanent pacemaker implantation will be recorded
Device Thrombosis	12 months after the index procedure	The number of participants who have been identified with device thrombosis will be recorded
Tricuspid Regurgitation Severity	12 months after the index procedure	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
Quality of Life - Kansas City Cardiomyopathy Questionnaire	12 months after the index procedure	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

Trial Locations

Locations (4)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Chu De Bordeaux - Haut-Lévêque Hospital; 🇫🇷 Bordeaux, Pessac, France

St Thomas Elgin General Hospital; 🇨🇦 Saint Thomas, Ontario, Canada

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States