NCT06033274

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
7 countries

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2023Aug 2026

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

September 5, 2023

Last Update Submit

September 3, 2025

Conditions

Tricuspid Regurgitation

Keywords

valvular heart diseasetricuspid regurgitationtranscatheter tricuspid valve replacement

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Permanent Pacemaker Implantation

    30 days after the index procedure

  • Combined all-cause mortality or rehospitalization for congestive heart failure

    12 months after the index procedure

  • All-cause mortality

    12 months after the index procedure

  • Hospitalization for congestive heart failure

    12 months after the index procedure

  • The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure

    12 months after the index procedure

  • +4 more secondary outcomes

Study Arms (1)

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

Device: Transcatheter Tricuspid Valve Replacement

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

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

Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Arizona Heart Hospital (Biltmore Cardiology)

Phoenix, Arizona, 85016, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

ENROLLING BY INVITATION

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

St Michael's Hospital, University of Toronto

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

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

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Chu De Bordeaux - Haut-Lévêque Hospital

Bordeaux, Pessac, 33600, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

Clinique Pasteur Toulouse

Toulouse, 31300, France

RECRUITING

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

Bad Oeynhausen, 32545, Germany

RECRUITING

Heart Center Cologne, University of Cologne

Cologne, 50924, Germany

RECRUITING

Cardiovascular Center (CVC) Frankfurt, Division of Cardiology

Frankfurt, 60389, Germany

RECRUITING

University Heart and Vascular Center, Department of Cardiology

Hamburg, 20251, Germany

RECRUITING

University Heart Center, Schleswig-Holstein University

Lübeck, D-23538, Germany

RECRUITING

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

Munich, 80333, Germany

RECRUITING

San Raffaele University Hospital

Milan, 20132, Italy

RECRUITING

Centro Cardiologico Monzino IRCCS

Milan, 20138, Italy

RECRUITING

University Hospital Alvaro Cunqueiro (CHUVI)

Vigo, Pontevedra, 36312, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40637674RESULT

  • 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.

    PMID: 41575411DERIVED

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andrea Scotti, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

  • Azeem Latib, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

  • Rishi Puri, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Neil Fam, MD

    St. Michaels Hospital

    PRINCIPAL INVESTIGATOR

  • Thomas Modine, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scotti, MD

CONTACT

7189043388ascotti@montefiore.org

Rishi Puri, MD

CONTACT

(216) 444-2273purir@ccf.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

October 5, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(5)ES(1)FR(3)IT(2)CA(3)DE(6)DK(1)