Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
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 Valve Replacement.
- Who it may be relevant to
- Registry conditions: Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases. Basic parameters: No limits · 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
- Germany, 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 →
Official title
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
Overview
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Detailed description
This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years.
Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.
Interventions
- Device Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Primary outcome measures
- Tricuspid regurgitation grade [Time frame: Up to 7 days, 30 days, and 1 year]
- Number of patients with major adverse events (MAE rates) [Time frame: 30 days]
Secondary outcome measures (6)
- All-cause mortality [Time frame: 30 days, 1 year, and 2 years]
- Cardiovascular mortality [Time frame: 30 days, 1 year, and 2 years]
- Heart failure hospitalizations [Time frame: 30 days, 1 year, and 2 years]
- Tricuspid valve re-intervention [Time frame: 30 days, 1 year, and 2 years]
- Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores [Time frame: 30 days, 1 year, and 2 years]
- NYHA Functional Class [Time frame: 30 days, 1 year, and 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Herz-und Diabeteszentrum NRW — Bad Oeynhausen
Switzerland · 1 center
- Inselspital — Bern
Identifiers
NCT: NCT06569602 · 2024-07