A Post-Market Assessment of the Safety and Performance of... | NCT07586995

Studies
A Post-Market Assessment of the Safety and Performance of the TriClip™ System

NCT07586995

Sponsor

Abbott Medical Devices

Status

Recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Tricuspid Regurgitation (TR)

Interventions

Tricuspid Transcatheter Edge-to-Edge Repair (TEER)

Countries

United States
Italy
Spain

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

Jun 2026

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

Jun 2026Estimated

Primary Completion Date

Sep 2028Estimated

Completion Date

Aug 2033Estimated

First Submitted Date

May 8, 2026

First Submission Date that Met QC Criteria

May 8, 2026

First Posted Date

May 14, 2026Actual

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

Jun 30, 2026

Last Update Posted Date

Jul 2, 2026Actual

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.

Detailed Description

TREAT TR is a prospective, observational, single-arm, multi-center, post-market study designed to confirm the safety and performance of the TriClip System in a contemporary, real-world setting in accordance with its approved indications for use. The study will be conducted at up to 100 centers globally. Clinical investigation assessments will be conducted prior to the procedure to assess eligibility. Follow-up visits after the TriClip procedure will occur at discharge, 30 days, 6 months (telephone), 12 months, and annually through 5-years. An independent echocardiographic core laboratory (ECL) will be utilized for evaluating echocardiograms. An imaging substudy will be conducted at a subset of participating sites in up to 250 subjects who consent to participate in the substudy. Cardiac-gated computed tomography (CT) will be performed at baseline and 12 months to evaluate reverse cardiac remodeling.

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

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Tricuspid Transcatheter Edge-to-Edge Repair (TEER)	Device	TriClip System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Peri-Procedural Adverse Events	Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding	Through 30 days post-procedure
Tricuspid Regurgitation (TR) grade less than or equal to moderate		At 30-day follow-up
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points	All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.	At 30-day follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
Subject agrees to attend follow-up assessments.
Subject is ≥ 18 years of age (or legal age of consent) at time of consent.

Exclusion Criteria:

Subject is participating in another clinical study that could impact the follow-up or results of this study.
Subject has an existing TriClip implant
Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.

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

This clinical investigation will enroll subjects from the general population who are scheduled to undergo the TriClip procedure per the current approved regional IFU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Allison Wood	Contact	612-518-9034		allison.wood@abbott.com
Jennifer Studt	Contact	314-616-2790		jennifer.studt@abbott.com

Overall Officials

Name	Affiliation	Role
Meghan Griffin	Abbott	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Health	Not yet recruiting	La Jolla	California	92037	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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