Clinical trial NCT06033274: Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Official title: Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tricuspid Regurgitation
Keywords: valvular heart disease
tricuspid regurgitation
transcatheter tricuspid valve replacement
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: University of Toronto
name: University Hospital, Bordeaux
First posted: 2023-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age under 18 years

Primary outcomes:
measure: Freedom from device-related complications
timeFrame: 30 days after the index procedure
measure: Reduction in Tricuspid Regurgitation Severity
timeFrame: 30 days after the index procedure
Secondary outcomes:
measure: Permanent Pacemaker Implantation
timeFrame: 30 days after the index procedure
measure: Combined all-cause mortality or rehospitalization for congestive heart failure
timeFrame: 12 months after the index procedure
measure: All-cause mortality
timeFrame: 12 months after the index procedure
measure: Hospitalization for congestive heart failure
timeFrame: 12 months after the index procedure
measure: The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure
timeFrame: 12 months after the index procedure
measure: Device Thrombosis
timeFrame: 12 months after the index procedure
measure: Tricuspid Regurgitation Severity
timeFrame: 12 months after the index procedure
measure: Quality of Life - Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 months after the index procedure
measure: Tricuspid Valve Reintervention
timeFrame: 12 months after the index procedure
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Saint Thomas
country: Canada
facility: St Thomas Elgin General Hospital
state: Ontario
city: Bordeaux
country: France
facility: Chu De Bordeaux - Haut-Lévêque Hospital
state: Pessac
Study officials:
affiliation: Montefiore Medical Center
name: Andrea Scotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Azeem Latib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Rishi Puri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michaels Hospital
name: Neil Fam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Thomas Modine, MD
role: PRINCIPAL_INVESTIGATOR
References: