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NCT Number: NCT06569602

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

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Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter Tricuspid Valve Replacement

Device

Replacement of the tricuspid valve through a transcatheter approach

Other names: Edwards EVOQUE Tricuspid Valve Replacement System

Primary outcomes

  1. Tricuspid regurgitation grade

    Time frame: Up to 7 days, 30 days, and 1 year

    Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)

  2. Number of patients with major adverse events (MAE rates)

    Time frame: 30 days

    The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days, 1 year, and 2 years

    Number of participants with all-cause mortality

  2. Cardiovascular mortality

    Time frame: 30 days, 1 year, and 2 years

    Number of participants with cardiovascular mortality

  3. Heart failure hospitalizations

    Time frame: 30 days, 1 year, and 2 years

    Number of patients with heart failure hospitalizations

  4. Tricuspid valve re-intervention

    Time frame: 30 days, 1 year, and 2 years

    Number of participants with tricuspid valve re-intervention

  5. Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores

    Time frame: 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).

  6. NYHA Functional Class

    Time frame: 30 days, 1 year, and 2 years

    Number of patients with improvement in NYHA class

Study contacts

Contact information is provided by the study sponsor or research team.

TMTT Clinical

CONTACT

[email protected]

+1-949-250-2500 or ext. +1800-424-3278

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device

Important dates

Study start
2024
Primary completion
2030
Study completion
2033
First posted
Aug 26, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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