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Recruiting NCT03416166

International Multisite Transcatheter Tricuspid Valve Therapies Registry

— Observational Severe Tricuspid Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Tricuspid Intervention.
Who it may be relevant to
Registry conditions: Severe Tricuspid Regurgitation. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Transcatheter Tricuspid Intervention
    Any available transcatheter tricuspid valve intervention

Primary outcome measures

  • Cardiovascular Death [Time frame: 30 days]
Secondary outcome measures (2)
  • NYHA Class [Time frame: 30 days, 1 year]
  • TR Reduction [Time frame: 30 days, 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Switzerland · 1 center
  • University Hospital Zurich — Zurich

Publications

  • Russo G, Pedicino D, Pires Marafon D, Adamo M, Alessandrini H, Andreas M, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Hahn RT, Harr C, Hausleiter J, Himbert D, Kalbacher D, Ho E, Latib A, Lentini N, Lubos E, Ludwig S, Lurz P, Metra M, Monivas V, Nickenig G, Pastorino R, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Besler C, Rommel KP, Schofer J, Scotti A, Piayda K, Sievert H, Tang PMID 39322365
  • Russo G, Hahn RT, Alessandrini H, Andreas M, Badano LP, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Gavazzoni M, Hausleiter J, Himbert D, Kalbacher D, Latib A, Lubos E, Ludwig S, Lurz P, Monivas V, Nickenig G, Pedicino D, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Rommel KP, Schofer J, Sievert H, Tang G, Thiele H, Unterhuber M, von Bardeleben RS, Webb J, Windecker S, Leon M, Mai PMID 38437953
  • Scotti A, Coisne A, Taramasso M, Granada JF, Ludwig S, Rodes-Cabau J, Lurz P, Hausleiter J, Fam N, Kodali SK, Rosiene J, Feinberg A, Pozzoli A, Alessandrini H, Biasco L, Brochet E, Denti P, Estevez-Loureiro R, Frerker C, Ho EC, Monivas V, Nickenig G, Praz F, Puri R, Sievert H, Tang GHL, Andreas M, Von Bardeleben RS, Rommel KP, Muntane-Carol G, Gavazzoni M, Braun D, Koell B, Kalbacher D, Connelly K PMID 36445158
  • 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 PMID 33541097
  • 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, Pr PMID 32912460

Identifiers

NCT: NCT03416166 · 2016-01753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗