Clinical trial NCT06569602: Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Official title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Tricuspid regurgitation grade
timeFrame: Up to 7 days, 30 days, and 1 year
measure: Number of patients with major adverse events (MAE rates)
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days, 1 year, and 2 years
measure: Cardiovascular mortality
timeFrame: 30 days, 1 year, and 2 years
measure: Heart failure hospitalizations
timeFrame: 30 days, 1 year, and 2 years
measure: Tricuspid valve re-intervention
timeFrame: 30 days, 1 year, and 2 years
measure: Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores
timeFrame: 30 days, 1 year, and 2 years
measure: NYHA Functional Class
timeFrame: 30 days, 1 year, and 2 years
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Herz-und Diabeteszentrum NRW, Bad Oeynhausen
name: Volker Rudolph, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern, Insespital, Switzerland
name: Fabien Praz, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: