Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences
About this trial
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.
Patient agrees to attend follow-up assessments.
Patients provided written informed consent for participation in the study.
Disqualifiers
Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
Any patient considered to be part of a vulnerable population.
Trial population
Patients with at least severe tricuspid regurgitation who are candidates for transcatheter tricuspid valve replacement, selected to receive treatment with the EVOQUE system per the current Instructions for use, and meet the eligibility requirements.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transcatheter Tricuspid Valve Replacement
DeviceReplacement of the tricuspid valve through a transcatheter approach
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Treatment1 intervention
Trial outcomes
Primary outcomes
1
Tricuspid regurgitation grade
Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)
Time frame
Up to 7 days, 30 days, and 1 year2
Number of patients with major adverse events (MAE rates)
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Time frame
30 daysSecondary outcomes
1
All-cause mortality
Number of participants with all-cause mortality
Time frame
30 days, 1 year, and 2 years2
Cardiovascular mortality
Number of participants with cardiovascular mortality
Time frame
30 days, 1 year, and 2 years3
Heart failure hospitalizations
Number of patients with heart failure hospitalizations
Time frame
30 days, 1 year, and 2 years4
Tricuspid valve re-intervention
Number of participants with tricuspid valve re-intervention
Time frame
30 days, 1 year, and 2 yearsSponsors and contacts
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Source ClinicalTrials.gov