International Multisite Transcatheter Tricuspid Valve Therapies Registry (TriValve)

For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).

Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.

The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.

Study Overview

• Status: Recruiting
• Conditions: Severe Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Intervention

• Study Type: Observational
• Enrollment (Anticipated): 269

Contacts and Locations

• Study Contact: Name: Maurizio Taramasso, MD, PhD; Phone Number: 0041442553728; Email: maurizio.taramasso@usz.ch

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zurich
    • Contact: Maurizio Taramasso, MD, PhD; Phone Number: 0041442553728; Email: maurizio.taramasso@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe symptomatic tricuspid regurgitation

Description

Inclusion Criteria:

• All the patients undergoing transcatheter tricuspid valve intervention.

General inclusion criteria:

• Minimal age: 18 years
• Patient is able to give written informed consent to the procedure

Exclusion Criteria:

• Patients not fulfilling the indications for transcatheter tricuspid intervention

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular Death	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
NYHA Class	30 days, 1 year
TR Reduction	30 days, 1 year

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• Muntane-Carol G, Taramasso M, Miura M, Gavazzoni M, Pozzoli A, Alessandrini H, Latib A, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Harr C, Lauten A, Lurz J, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Philippon F, Praz F, Puri R, Schafer U, Schofer J, Sievert H, Tang GHL, Khattab AA, Andreas M, Russo M, Thiele H, Unterhuber M, Himbert D, Urena M, von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, Rodes-Cabau J. Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry. Circ Cardiovasc Interv. 2021 Feb;14(2):e009685. doi: 10.1161/CIRCINTERVENTIONS.120.009685. Epub 2021 Feb 5.
• Miura M, Alessandrini H, Alkhodair A, Attinger-Toller A, Biasco L, Lurz P, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Estevez-Loureiro R, Fam N, Frerker C, Gavazzoni M, Hausleiter J, Himbert D, Ho E, Juliard JM, Kaple R, Besler C, Kodali S, Kreidel F, Kuck KH, Latib A, Lauten A, Monivas V, Mehr M, Muntane-Carol G, Nazif T, Nickenig G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodes-Cabau J, Schafer U, Schofer J, Sievert H, Tang GHL, Thiele H, Rommel KP, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Maisano F, Hahn RT, Taramasso M; TriValve Investigators. Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1999-2009. doi: 10.1016/j.jcin.2020.05.011.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 15, 2017
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: tricuspid regurgitation; Tricuspid Valve; transcatheter tricuspid regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2016-01753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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