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

NCT06569602 | Recruiting FDA Device

• 1 other identifier: 2024-07
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Tricuspid regurgitation grade

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

  Up to 7 days, 30 days, and 1 year

• Number of patients with major adverse events (MAE rates)

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

  30 days

Secondary Outcomes (6)

• All-cause mortality

  30 days, 1 year, and 2 years

• Cardiovascular mortality

  30 days, 1 year, and 2 years

• Heart failure hospitalizations

  30 days, 1 year, and 2 years

• Tricuspid valve re-intervention

  30 days, 1 year, and 2 years

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

  30 days, 1 year, and 2 years

Study Arms (1)

Treatment

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Device: Transcatheter Tricuspid Valve Replacement

Interventions

Transcatheter Tricuspid Valve Replacement DEVICE

Replacement of the tricuspid valve through a transcatheter approach

Also known as: Edwards EVOQUE Tricuspid Valve Replacement System

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (2)

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Inselspital

Bern, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Valve Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Volker Rudolph, Prof. MD

  Herz-und Diabeteszentrum NRW, Bad Oeynhausen

  PRINCIPAL INVESTIGATOR

• Fabien Praz, Prof. MD

  Bern, Insespital, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TMTT Clinical

CONTACT

+1-949-250-2500 or; TMTT_Clinical@Edwards.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2033
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

CH (1); DE (1)