Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment (TRIPLACE)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Replacement

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Andrea Scotti, MD; Phone Number: 7189043388; Email: ascotti@montefiore.org
• Study Contact Backup: Name: Rishi Puri, MD; Phone Number: (216) 444-2273; Email: purir@ccf.org

Study Locations

• Canada
  • Ontario
    • Saint Thomas, Ontario, Canada, N5R 5C4
      • St Thomas Elgin General Hospital
      • Principal Investigator: Neil Fam, MD
      • Contact: Neil Fam, MD; Phone Number: (647) 776-2500; Email: Neil.Fam@unityhealth.to
• France
  • Pessac
    • Bordeaux, Pessac, France, 33600
      • Chu De Bordeaux - Haut-Lévêque Hospital
      • Principal Investigator: Thomas Modine, MD
      • Contact: Thomas Modine, MD; Phone Number: 33 556795679; Email: thomasmodine@gmail.com
• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
      • Contact: Andrea Scotti, MD; Phone Number: +1 718-904-3388; Email: ascotti@montefiore.org
      • Contact: Azeem Latib, MD; Phone Number: +1 718-904-3388; Email: mlatib@montefiore.org
      • Principal Investigator: Azeem Latib, MD
      • Principal Investigator: Andrea Scotti, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
      • Contact: Rishi Puri, MD; Phone Number: 1 216-444-2273; Email: purir@ccf.org
      • Principal Investigator: Rishi Puri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age under 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Transcatheter Tricuspid Valve Replacement; All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permanent Pacemaker Implantation	The number of participants who have received a permanent pacemaker implantation will be recorded	30 days after the index procedure
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
All-cause mortality	The number of deaths due to any cause will be recorded	12 months after the index procedure
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
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
Device Thrombosis	The number of participants who have been identified with device thrombosis will be recorded	12 months after the index procedure
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
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
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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: The Cleveland Clinic; University of Toronto; University Hospital, Bordeaux
• Investigators: Principal Investigator: Azeem Latib, MD, Montefiore Medical Center; Principal Investigator: Thomas Modine, MD, University Hospital, Bordeaux; Principal Investigator: Andrea Scotti, MD, Montefiore Medical Center; Principal Investigator: Rishi Puri, MD, The Cleveland Clinic; Principal Investigator: Neil Fam, MD, St. Michaels Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: tricuspid regurgitation; valvular heart disease; transcatheter tricuspid valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2023-15312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No