Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation
Conditions
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.
Interventions
Replacement of the tricuspid valve through a transcatheter approach
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tricuspid regurgitation grade | Up to 7 days, 30 days, and 1 year | Number of patients with optimal TR grade (≤1 on a 0-5 grade scale) |
| Number of patients with major adverse events (MAE rates) | 30 days | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days, 1 year, and 2 years | Number of participants with all-cause mortality |
| Cardiovascular mortality | 30 days, 1 year, and 2 years | Number of participants with cardiovascular mortality |
| Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores | 30 days, 1 year, and 2 years | KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life). |
| Heart failure hospitalizations | 30 days, 1 year, and 2 years | Number of patients with heart failure hospitalizations |
| NYHA Functional Class | 30 days, 1 year, and 2 years | Number of patients with improvement in NYHA class |
| Tricuspid valve re-intervention | 30 days, 1 year, and 2 years | Number of participants with tricuspid valve re-intervention |
Countries
Germany, Greece, Italy, Spain, Switzerland, United Kingdom
Contacts
CONTACTTMTT Clinical
PRINCIPAL_INVESTIGATORVolker Rudolph, Prof. MD
Herz-und Diabeteszentrum NRW, Bad Oeynhausen
PRINCIPAL_INVESTIGATORFabien Praz, Prof. MD
Bern, Insespital, Switzerland
Outcome results
None listed