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NCT Number: NCT03416166

International Multisite Transcatheter Tricuspid Valve Therapies Registry

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, Switzerland

Location status: Recruiting

Location contact

Maurizio Taramasso, MD, PhD

CONTACT

[email protected]

0041442553728

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter Tricuspid Intervention

Device

Any available transcatheter tricuspid valve intervention

Primary outcomes

  1. Cardiovascular Death

    Time frame: 30 days

Secondary outcomes

  1. NYHA Class

    Time frame: 30 days, 1 year

  2. TR Reduction

    Time frame: 30 days, 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Maurizio Taramasso, MD, PhD

CONTACT

[email protected]

0041442553728

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: TriValve

Important dates

Study start
2016
Primary completion
2017
Study completion
2026
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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