Recruiting

TTVR

Sponsor:

Montefiore Medical Center

Code:

NCT06033274

Conditions

Tricuspid Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Tricuspid Valve Replacement

Study Details

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.

Conditions

Tricuspid Regurgitation

Study ID

NCT06033274

Start date

Oct 5, 2023

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18 years

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Transcatheter Tricuspid Valve Replacement

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

Primary outcome measure

  • Freedom from device-related complications [ Time Frame: 30 days after the index procedure ]
  • Reduction in Tricuspid Regurgitation Severity [ Time Frame: 30 days after the index procedure ]

Central Contacts and Locations

Central contacts

Andrea Scotti, MD

7189043388ascotti@montefiore.org

Rishi Puri, MD

(216) 444-2273purir@ccf.org

Locations

Arizona Heart Hospital (Biltmore Cardiology)

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Timothy Byrne, DO

tbyrne@biltmorecardiology.com

Principal Investigator:

Timothy Byrne, DO

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Rebecca T Hahn, MD

rth2@columbia.edu

Susheel Kodali, MD

sk2427@cumc.columbia.edu

Principal Investigator:

Rebecca Hahn, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Andrea Scotti, MD

718-904-3388ascotti@montefiore.org

Azeem Latib, MD

718-904-3388mlatib@montefiore.org

Principal Investigator:

Azeem Latib, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rishi Puri, MD

216-444-2273purir@ccf.org

Samir Kapadia, MD

kapadias@ccf.org

Principal Investigator:

Rishi Puri, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Robert Boone, MD

rboone@providencehealth.bc.ca

Anson Cheung, MD

acheung@providencehealth.bc.ca

Principal Investigator:

Robert Boone, MD

St Michael's Hospital, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Neil Fam, MD

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

Principal Investigator:

Neil Fam, MD

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

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Josep Rodés-Cabau, MD

josep.rodes@criucpq.ulaval.ca

Principal Investigator:

Josep Rodés-Cabau, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • valvular heart disease
  • tricuspid regurgitation
  • transcatheter tricuspid valve replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-09-10.