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Tricuspid RegurgitationTRIPLACENCT06033274

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

An observational study of Tricuspid Regurgitation, run by Montefiore Medical Center at 31 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Regurgitation
What is being tested?
Transcatheter Tricuspid Valve Replacement
Type of treatment
Medical device
How many people
800 participants
Where
31 sitesin 8 countries
Study dates
5 Oct 2023to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.

Who may be able to join

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

Who cannot join

  • Age under 18 years

Trial locations and contacts

31 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Andrea Scotti, MD contact

7189043388

ascotti@montefiore.org

Rishi Puri, MD contact

(216) 444-2273

purir@ccf.org

31 sites in 8 countries

United States9 sites, 9 recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Santiago Garcia, MD

    Raviteja Guddeti, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Rishi Puri, MD, 216-444-2273 ext. 1, purir@ccf.org

    Samir Kapadia, MD, kapadias@ccf.org

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Ryan K Kaple, MD

    Polydoros Kampaktsis, MD, kampaktsisp@gmail.com

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Rebecca T Hahn, MD, rth2@columbia.edu

    Susheel Kodali, MD, sk2427@cumc.columbia.edu

    Recruiting

  • Arizona Heart Hospital (Biltmore Cardiology)

    Phoenix, Arizona, 85016

    Timothy Byrne, DO, tbyrne@biltmorecardiology.com

    Akram W Ibrahim, MD

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Brandon M Jones, MD, PHPPRcontactus@providence.org

    Brandon M Jones, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Enrolling by invitation

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Andrea Scotti, MD, 718-904-3388 ext. +1, ascotti@montefiore.org

    Azeem Latib, MD, 718-904-3388 ext. +1, mlatib@montefiore.org

    Recruiting

  • Ascension Via Christi

    Wichita, Kansas, 67214

    Recruiting

Other trials in United States

Germany7 sites, 7 recruiting

  • Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University

    Bad Oeynhausen, 32545

    Tanja Rudolph, MD, trudolph@hdz-nrw.de

    Johannes Kirchner, MD, jkirchner@hdz-nrw.de

    Recruiting

  • Heart Center Cologne, University of Cologne

    Cologne, 50924

    Matti Adam, MD, matti.adam@uk-koeln.de

    Jonathan Curio, MD, jonathan.curio@uk-koeln.de

    Recruiting

  • University of Duisberg-Essen, West German Heart and Vascular Centre

    Essen, North Rhine-Westphalia, 45147

    Amir Abbas Mahabadi, MD, amir-abbas.mahabadi@uk-essen.de

    Amir Abbas Mahabadi, MD

    Recruiting

  • Cardiovascular Center (CVC) Frankfurt, Division of Cardiology

    Frankfurt am Main, Hesse, 60389

    Horst Sievert, MD, h.sievert@cvcfrankfurt.de

    Kerstin Piayda, MD, k.piayda@cvcfrankfurt.de

    Recruiting

  • University Heart and Vascular Center, Department of Cardiology

    Hamburg, 20251

    Sebastian Ludwig, MD, se.ludwig@uke.de

    Niklas Schofer, MD, n.schofer@uke.de

    Recruiting

  • University Heart Center, Schleswig-Holstein University

    Lübeck, Schleswig-Holstein, D-23538

    Christian Frerker, MD, privdoz.frerker@uksh.de

    Christoph Marquetand, MD, christoph.marquetand@uksh.de

    Recruiting

  • Medical Clinic and Polyclinic, University Hospital of Munich (LMU Klinikum)

    Munich, Bavaria, 80333

    Jörg Hausleiter, MD, joerg.hausleiter@med.uni-muenchen.de

    Lukas Stolz, MD, Lukas.Stolz@med.uni-muenchen.de

    Recruiting

Other trials in Germany

Canada4 sites, 4 recruiting

  • Montréal Heart Institute (MHI)

    Montreal, Quebec, H1T 1C8

    Walid Ben Ali, MD, PhD, dr.walidbenali@gmail.com

    Sebastián Mrad, MD

    Recruiting

  • Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada

    Québec, Quebec, G1V 4G5

    Josep Rodés-Cabau, MD, josep.rodes@criucpq.ulaval.ca

    Juan del Portillo, MD

    Recruiting

  • St Michael's Hospital, University of Toronto

    Toronto, Ontario, M5B 1W8

    Neil Fam, MD, (647) 776-2500, Neil.Fam@unityhealth.to

    Alexandru Patrascu, MD

    Recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Robert Boone, MD, rboone@providencehealth.bc.ca

    Anson Cheung, MD, acheung@providencehealth.bc.ca

    Recruiting

Other trials in Canada

France4 sites, 4 recruiting

  • Chu De Bordeaux - Haut-Lévêque Hospital

    Bordeaux, Pessac, 33600

    Thomas Modine, MD, 556795679 ext. 33, thomasmodine@gmail.com

    Thomas Modine, MD

    Recruiting

  • Centre Hospitalier Universitaire de Lille

    Lille, Hauts-de-France, 59000

    Augustin Coisne, MD, PhD, augustin.coisne@chru-lille.fr

    Arnaude Sudre, MD, a.sudre@yahoo.fr

    Recruiting

  • Hospital Center University De Lille (CHU Lille)

    Lille, Hauts-de-France, 59000

    Augustin Coisne, MD

    Arnaude Sudre, MD

    Recruiting

  • Clinique Pasteur Toulouse

    Toulouse, Haute-Garonne, 31300

    Didier Tchétché, MD, d.tchetche@clinique-pasteur.com

    Nicolas Dumonteil, MD, ndumonteil@clinique-pasteur.com

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

  • San Raffaele University Hospital

    Milan, Lombardy, 20132

    Francesco Maisano, MD, maisano.francesco@hsr.it

    Federica Gramegna, MD

    Recruiting

  • Centro Cardiologico Monzino IRCCS

    Milan, Lombardy, 20138

    Federico De Marco, MD, federico.demarco@gmail.com

    Matteo Biroli, MD, birolimatteo@gmail.com

    Recruiting

Other trials in Italy

Spain2 sites, 2 recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

    Ignacio J Amat Santos, MD, PhD, ijamat@gmail.com

    Mario Garcia Gomez, MD

    Recruiting

  • University Hospital Alvaro Cunqueiro (CHUVI)

    Vigo, Pontevedra, 36312

    Rodrigo Estevez-Loureiro, MD, roiestevez@hotmail.com

    Julio Echarte-Morales, MD, juliocecharte@gmail.com

    Recruiting

Other trials in Spain

Switzerland2 sites, 2 recruiting

  • University Hospital Basel

    Basel, Canton of Basel-City, 4031

    Mohammad Kassar, MD

    Mohammad Kassar, MD

    Recruiting

  • HerzZentrum Hirslanden Zürich

    Zurich, CH-8008

    Recruiting

Other trials in Switzerland

Denmark1 site, 1 recruiting

  • Rigshospitalet, Copenhagen University Hospital

    Copenhagen, Capital Region, 2100

    Ole De Backer, MD, ole.de.backer@regionh.dk

    Yusuke Kobari, MD

    Recruiting

Other trials in Denmark

About this study

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

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.

Read the 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.
Being tested
Transcatheter Tricuspid Valve Replacement
Keywords
valvular heart disease, tricuspid regurgitation, transcatheter tricuspid valve replacement
Medical subject headings
Tricuspid Valve Insufficiency, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter Tricuspid Valve ReplacementDevice

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

Study groups in NCT06033274
Study groupRoleWhat they receive
Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve ReplacementPatients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement
Receives: Device: Transcatheter Tricuspid Valve Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days after the index procedure

  2. 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

    Measured: 30 days after the index procedure

Secondary outcomes (9)

  1. Permanent Pacemaker Implantation

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

    Measured: 30 days after the index procedure

  2. 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

    Measured: 12 months after the index procedure

  3. All-cause mortality

    The number of deaths due to any cause will be recorded

    Measured: 12 months after the index procedure

  4. Hospitalization for congestive heart failure

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

    Measured: 12 months after the index procedure

  5. 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

    Measured: 12 months after the index procedure

  6. Device Thrombosis

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

    Measured: 12 months after the index procedure

  7. 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

    Measured: 12 months after the index procedure

  8. 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

    Measured: 12 months after the index procedure

  9. Tricuspid Valve Reintervention

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

    Measured: 12 months after the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start5 Oct 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06033274
Sponsor's protocol ID
2023-15312
Other IDs
2023
Acronym
TRIPLACE
Status last verified
Sep 2026
First submitted
5 Sep 2023
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40637674

  • 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.

    PubMed 41881643

  • 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 Mar;12(3):474-485. doi: 10.1016/j.jacep.2025.12.027. Epub 2026 Jan 22.

    PubMed 41575411

Questions about this trial

What is this clinical trial studying?

An observational study of Tricuspid Regurgitation, run by Montefiore Medical Center at 31 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Germany, Canada, France, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Scotti, MD (7189043388, ascotti@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from device-related complications (time frame: 30 days after the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06033274, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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