Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

International Multisite Transcatheter Tricuspid Valve Therapies Registry (TriValve)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416166
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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.


Condition or disease Intervention/treatment
Severe Tricuspid Regurgitation Device: Transcatheter Tricuspid Intervention

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 269 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: International Multisite Transcatheter Tricuspid Valve Therapies Registry
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : May 15, 2017
Estimated Study Completion Date : November 1, 2026

Intervention Details:
  • Device: Transcatheter Tricuspid Intervention
    Any available transcatheter tricuspid valve intervention


Primary Outcome Measures :
  1. Cardiovascular Death [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. NYHA Class [ Time Frame: 30 days, 1 year ]
  2. TR Reduction [ Time Frame: 30 days, 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe symptomatic tricuspid regurgitation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416166


Contacts
Layout table for location contacts
Contact: Maurizio Taramasso, MD, PhD 0041442553728 maurizio.taramasso@usz.ch

Locations
Layout table for location information
Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland
Contact: Maurizio Taramasso, MD, PhD    0041442553728    maurizio.taramasso@usz.ch   
Sponsors and Collaborators
University of Zurich
Additional Information:

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03416166    
Other Study ID Numbers: 2016-01753
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Tricuspid Valve
tricuspid regurgitation
transcatheter tricuspid regurgitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases