Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| University of Toronto | OTHER |
| University Hospital, Bordeaux | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
The primary aims of the registry will be:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Tricuspid Regurgitation undergoing 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Tricuspid Valve Replacement | Device | All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Scotti, MD | Contact | 7189043388 | ascotti@montefiore.org | |
| Rishi Puri, MD | Contact | (216) 444-2273 | purir@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Scotti, MD | Montefiore Medical Center | Principal Investigator |
| Azeem Latib, MD | Montefiore Medical Center | Principal Investigator |
| Rishi Puri, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Hospital (Biltmore Cardiology) | Recruiting | Phoenix | Arizona | 85016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40637674 | Result | Scotti A, Puri R, Sturla M, Zahr F, Boone R, Kodali S, Tchetche 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, Rodes-Cabau J, Schofer N, Granada J, Hausleiter J, Hahn RT, Modine T, Fam N, Latib A. Incidence, Predictors, and Management of Conduction Disturbances After Transcatheter Tricuspid Valve Replacement: The TRIPLACE Registry. JACC Cardiovasc Interv. 2025 Jul 28;18(14):1789-1799. doi: 10.1016/j.jcin.2025.05.029. Epub 2025 Jul 9. | |
| 41881643 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| The Cleveland Clinic |
| Principal Investigator |
| Neil Fam, MD | St. Michaels Hospital | Principal Investigator |
| Thomas Modine, MD | University Hospital, Bordeaux | Principal Investigator |
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Oregon Health & Science University | Enrolling by invitation | Portland | Oregon | 97239 | United States |
| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
|
| St Michael's Hospital, University of Toronto | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
|
| Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
|
| Rigshospitalet, Copenhagen University Hospital | Recruiting | Copenhagen | 2100 | Denmark |
|
| Chu De Bordeaux - Haut-Lévêque Hospital | Recruiting | Bordeaux | Pessac | 33600 | France |
|
| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
|
| Clinique Pasteur Toulouse | Recruiting | Toulouse | 31300 | France |
|
| Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University | Recruiting | Bad Oeynhausen | 32545 | Germany |
|
| Heart Center Cologne, University of Cologne | Recruiting | Cologne | 50924 | Germany |
|
| Cardiovascular Center (CVC) Frankfurt, Division of Cardiology | Recruiting | Frankfurt | 60389 | Germany |
|
| University Heart and Vascular Center, Department of Cardiology | Recruiting | Hamburg | 20251 | Germany |
|
| University Heart Center, Schleswig-Holstein University | Recruiting | Lübeck | D-23538 | Germany |
|
| Medical Clinic and Polyclinic, University Hospital of Munich (LMU Klinikum) | Recruiting | Munich | 80333 | Germany |
|
| San Raffaele University Hospital | Recruiting | Milan | 20132 | Italy |
|
| Centro Cardiologico Monzino IRCCS | Recruiting | Milan | 20138 | Italy |
|
| University Hospital Alvaro Cunqueiro (CHUVI) | Recruiting | Vigo | Pontevedra | 36312 | Spain |
|
| Derived |
| Scotti A, Latib A, Filtz A, Sturla M, Zahr F, Boone R, Kodali S, Tchetche D, De Backer O, Coisne A, Ludwig S, Garcia SA, Stolz L, Loureiro RE, Adam M, De Marco F, Ho EC, Cheung A, Biroli M, 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, Guddeti R, Bakhtadze B, Krishnaswamy A, Kapadia SR, Portillo JD, Rodes-Cabau J, Schofer N, Cruz-Gonzalez I, Granada J, Hausleiter J, Hahn RT, Modine T, Fam N, Puri R. Incidence, Clinical Implications, and Predictors of Paravalvular Leak Following Transcatheter Tricuspid Valve Replacement: The TRIPLACE Registry. JACC Cardiovasc Interv. 2026 Mar 23;19(6):680-693. doi: 10.1016/j.jcin.2026.01.281. |
| 41575411 | Derived | Traynor BP, Scotti A, Puri R, Sturla M, Zahr F, Boone R, Kodali S, Tchetche 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, Rodes-Cabau J, Schofer N, Granada JF, Hausleiter J, Hahn RT, Modine T, Latib A, Fam N. Transcatheter Tricuspid Valve Replacement in Patients With Cardiac Implantable Electronic Device Leads: The TRIPLACE Registry. JACC Clin Electrophysiol. 2026 Jan 20:S2405-500X(25)01104-1. doi: 10.1016/j.jacep.2025.12.027. Online ahead of print. |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided