Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Tricuspid Regurgitation Clinical Trial

— TRIPLACE  

Official title:

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06033274
• Other study ID #: 2023-15312
• Status: Enrolling by invitation
• Start date: October 5, 2023
• Est. completion date: August 2027

Study information

• Verified date: October 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: August 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing Transcatheter Tricuspid Valve Replacement

• Native Tricuspid Valve disease

• Orthotopic Tricuspid Valve Implantation

Exclusion Criteria:

• Age under 18 years

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Canada	St Thomas Elgin General Hospital	Saint Thomas	Ontario
France	Chu De Bordeaux - Haut-Lévêque Hospital	Bordeaux	Pessac
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Montefiore Medical Center	The Cleveland Clinic, University Hospital, Bordeaux, University of Toronto

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Permanent Pacemaker Implantation	The number of participants who have received a permanent pacemaker implantation will be recorded	30 days after the index procedure
Secondary	Combined all-cause mortality or rehospitalization for congestive heart failure	The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded	12 months after the index procedure
Secondary	All-cause mortality	The number of deaths due to any cause will be recorded	12 months after the index procedure
Secondary	Hospitalization for congestive heart failure	The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded	12 months after the index procedure
Secondary	The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure	The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded.; NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest; NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients	12 months after the index procedure
Secondary	Device Thrombosis	The number of participants who have been identified with device thrombosis will be recorded	12 months after the index procedure
Secondary	Tricuspid Regurgitation Severity	Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted 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. Higher mean scores are indicative of greater TR severity	12 months after the index procedure
Secondary	Quality of Life - Kansas City Cardiomyopathy Questionnaire	Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life	12 months after the index procedure
Secondary	Tricuspid Valve Reintervention	The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded	12 months after the index procedure