Real World European Investigation of Safety and Clinical... | NCT06569602

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Sep 30, 2030Estimated

Completion Date

Sep 30, 2033Estimated

First Submitted Date

Aug 12, 2024

First Submission Date that Met QC Criteria

Aug 21, 2024

First Posted Date

Aug 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2024

Last Update Posted Date

Oct 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment		Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Tricuspid Valve Replacement	Device	Replacement of the tricuspid valve through a transcatheter approach	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
All-cause mortality	Number of participants with all-cause mortality	30 days, 1 year, and 2 years
Cardiovascular mortality	Number of participants with cardiovascular mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TMTT Clinical	Contact	+1-949-250-2500 or	+1800-424-3278	TMTT_Clinical@Edwards.com

Overall Officials

Name	Affiliation	Role
Volker Rudolph, Prof. MD	Herz-und Diabeteszentrum NRW, Bad Oeynhausen	Principal Investigator
Fabien Praz, Prof. MD	Bern, Insespital, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz-und Diabeteszentrum NRW	Recruiting	Bad Oeynhausen			Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D014262	Tricuspid Valve Insufficiency
D006349	Heart Valve Diseases
D002318	Cardiovascular Diseases