Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Conditions

Tricuspid Regurgitation

Keywords

valvular heart disease, tricuspid regurgitation, transcatheter tricuspid valve replacement

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.

Traynor BP, Scotti A, Puri R, Sturla M, Zahr F, Boone R, Kodali S, Tchétché D, De Backer O, Coisne A, Ludwig S, Stolz L, Loureiro RE, Adam M, De Marco F, Biroli M, Ho EC, Cheung A, Patrascu A, Alnasser S, Chadderdon S, Lulic D, Bartkowiak J, Echarte-Morales J, Sievert H, Byrne T, Maisano F, Frerker C, Dumonteil N, Oliva OA, Rudolph TK, Rudolph F, Krishnaswamy A, Kapadia SR, Portillo JD, Rodés-Cabau J, Schofer N, Granada JF, Hausleiter J, Hahn RT, Modine T, Latib A, Fam N.

2026-01-20

10.1016/j.jacep.2025.12.027

Incidence, Predictors, and Management of Conduction Disturbances After Transcatheter Tricuspid Valve Replacement: The TRIPLACE Registry.

Scotti A, Puri R, Sturla M, Zahr F, Boone R, Kodali S, Tchétché D, De Backer O, Coisne A, Ludwig S, Stolz L, Estevez Loureiro R, Adam M, De Marco F, Ho EC, Cheung A, Moey M, Ong G, Chadderdon S, Lulic D, Bartkowiak J, Echarte J, Sievert H, Byrne T, Maisano F, Frerker C, Dumonteil N, Oliva OA, Rudolph TK, Kirchner J, Bakhtadze B, Kapadia SR, Rodés-Cabau J, Schofer N, Granada J, Hausleiter J, Hahn RT, Modine T, Fam N, Latib A.

2025-07-094 citations

10.1016/j.jcin.2025.05.029

Interventions

DEVICETranscatheter Tricuspid Valve Replacement

All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

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

Exclusion criteria

* Age under 18 years

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Permanent Pacemaker Implantation	30 days after the index procedure	The number of participants who have received a permanent pacemaker implantation will be 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
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
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
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
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

Countries

Canada, Denmark, France, Germany, Italy, Spain, Switzerland, United States

Contacts

CONTACTAndrea Scotti, MD

ascotti@montefiore.org7189043388

CONTACTRishi Puri, MD

purir@ccf.org(216) 444-2273

PRINCIPAL_INVESTIGATORAndrea Scotti, MD

Montefiore Medical Center

PRINCIPAL_INVESTIGATORAzeem Latib, MD

Montefiore Medical Center

PRINCIPAL_INVESTIGATORRishi Puri, MD

The Cleveland Clinic

PRINCIPAL_INVESTIGATORNeil Fam, MD

St. Michaels Hospital

PRINCIPAL_INVESTIGATORThomas Modine, MD

University Hospital, Bordeaux

Outcome results

None listed