NCT06569602 Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
| NCT ID | NCT06569602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Tricuspid Valve Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2030-09-30 |
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 500 participants in total. It began in 2024-10-01 with a primary completion date of 2030-09-30.
⚠ 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
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patient agrees to attend follow-up assessments. 3. Patients provided written informed consent for participation in the study. Exclusion Criteria: 1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s). 2. Any patient considered to be part of a vulnerable population.
Contact & Investigator
Volker Rudolph, Prof. MD
PRINCIPAL INVESTIGATOR
Herz-und Diabeteszentrum NRW, Bad Oeynhausen
Frequently Asked Questions
Who can join the NCT06569602 clinical trial?
This trial is open to participants of all sexes, studying Tricuspid Valve Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06569602 currently recruiting?
Yes, NCT06569602 is actively recruiting participants. Contact the research team at TMTT_Clinical@Edwards.com for enrollment information.
Where is the NCT06569602 trial being conducted?
This trial is being conducted at Bad Berka, Germany, Bad Nauheim, Germany, Bad Neustadt an der Saale, Germany, Bad Oeynhausen, Germany and 11 additional locations.
Who is sponsoring the NCT06569602 clinical trial?
NCT06569602 is sponsored by Edwards Lifesciences. The principal investigator is Volker Rudolph, Prof. MD at Herz-und Diabeteszentrum NRW, Bad Oeynhausen. The trial plans to enroll 500 participants.