Recruiting

TTVRGlobal Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

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, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

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

7189043388 ascotti@montefiore.org

Rishi Puri, MD

(216) 444-2273 purir@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

Ascension Via Christi

Recruiting

Wichita, Kansas, United States, 67214

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Polydoros Kampaktsis, MD

kampaktsisp@gmail.com

Principal Investigator:

Ryan K Kaple, MD

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 T Hahn, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Andrea Scotti, MD

718-904-3388 ascotti@montefiore.org

Azeem Latib, MD

718-904-3388 mlatib@montefiore.org

Principal Investigator:

Azeem Latib, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Santiago Garcia, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rishi Puri, MD

216-444-2273 purir@ccf.org

Samir Kapadia, MD

kapadias@ccf.org

Principal Investigator:

Rishi Puri, MD

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Brandon M Jones, MD

PHPPRcontactus@providence.org

Principal Investigator:

Brandon M Jones, 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) 776-2500 Neil.Fam@unityhealth.to

Principal Investigator:

Neil Fam, MD

Montréal Heart Institute (MHI)

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Walid Ben Ali, MD, PhD

dr.walidbenali@gmail.com

Principal Investigator:

Walid Ben Ali, 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 15, 2026

Last verified

Sep, 2026

Keywords

valvular heart disease
tricuspid regurgitation
transcatheter tricuspid valve replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.