Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Montefiore Medical Center
Study ID
NCT06033274
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 13, 2023
Start date
Oct 5, 2023
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Freedom from device-related complications [ Time Frame: 30 days after the index procedure ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Arizona Heart Hospital (Biltmore Cardiology)PhoenixArizona85016
Timothy Byrne, DO
[email protected]
Akram W Ibrahim, MD
Timothy Byrne, DO (PRINCIPAL_INVESTIGATOR)
Ascension Via ChristiWichitaKansas67214-
Hackensack University Medical CenterHackensackNew Jersey07601
Ryan K Kaple, MD
Polydoros Kampaktsis, MD
[email protected]
Ryan K Kaple, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Rebecca T Hahn, MD
[email protected]
Susheel Kodali, MD
[email protected]
Rebecca T Hahn, MD (PRINCIPAL_INVESTIGATOR)
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10461
Andrea Scotti, MD
[email protected]
718-904-3388
Azeem Latib, MD
[email protected]
718-904-3388
Azeem Latib, MD (PRINCIPAL_INVESTIGATOR)
Andrea Scotti, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Santiago Garcia, MD
Raviteja Guddeti, MD
Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Rishi Puri, MD
[email protected]
216-444-2273
Samir Kapadia, MD
[email protected]
Rishi Puri, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239-
Providence St. Vincent Medical CenterPortlandOregon97225
Brandon M Jones, MD
[email protected]
Brandon M Jones, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Arizona Heart Hospital (Biltmore Cardiology)· Phoenix, AZAscension Via Christi· Wichita, KSHackensack University Medical Center· Hackensack, NJColumbia University Irving Medical Center· New York, NYMontefiore Medical Center· The Bronx, NYThe Christ Hospital· Cincinnati, OH

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