NCT03416166 International Multisite Transcatheter Tricuspid Valve Therapies Registry
| NCT ID | NCT03416166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Severe Tricuspid Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 269 participants |
| Start Date | 2016-11-01 |
| Primary Completion | 2017-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 269 participants in total. It began in 2016-11-01 with a primary completion date of 2017-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03416166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Severe Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03416166 currently recruiting?
Yes, NCT03416166 is actively recruiting participants. Contact the research team at maurizio.taramasso@usz.ch for enrollment information.
Where is the NCT03416166 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT03416166 clinical trial?
NCT03416166 is sponsored by University of Zurich. The trial plans to enroll 269 participants.