TriClip CED RWE Study | NCT06920745

Studies
TriClip CED RWE Study

NCT06920745

Sponsor

Abbott Medical Devices

Status

Recruiting

Last Update Posted

Aug 11, 2025Actual

Enrollment

2,200Estimated

Phase

Not provided

Conditions

Tricuspid Regurgitation

Interventions

The TriClip System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

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

Jul 8, 2025Actual

Primary Completion Date

Jul 2032Estimated

Completion Date

Jul 2032Estimated

First Submitted Date

Apr 3, 2025

First Submission Date that Met QC Criteria

Apr 3, 2025

First Posted Date

Apr 10, 2025Actual

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

Aug 6, 2025

Last Update Posted Date

Aug 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.

Detailed Description

The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.

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

2,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group		Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system	Device: The TriClip System
Control Group		Patients with symptomatic, severe or greater TR without T-TEER

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The TriClip System	Device	The TriClip System	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of heart failure hospitalization or all-cause mortality	Compare the rate of composite endpoint at 2 years between the treatment and control groups.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Tricuspid valve re-intervention	Report the rate at 2 years for the treatment group	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 18 years of age at time of implant
Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)

Exclusion Criteria:

Patients with less than severe Tricuspid Regurgitation
Patients with a prior history of surgical or transcatheter tricuspid valve replacement
Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Real-world patients with symptomatic, severe or greater tricuspid regurgitation in the United States

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TRICARE	Contact	(408) 845-3000		TRICARE@abbott.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abbott	Recruiting	Santa Clara	California	95054	United States

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided