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

NCT07586995 | Enrolling By Invitation FDA Device

• 1 other identifier: ABT-CIP-10594
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 3

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.

Conditions

Tricuspid Regurgitation (TR)

Keywords

Tricuspid Regurgitation; Tricuspid; Cardiovascular; Tricuspid Valve Insufficiency; ABT-CIP-10594; Tricuspid Regurgitation (TR); Transcatheter Edge-To-Edge Repair (TEER)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

  At 30-day follow-up

Interventions

Tricuspid Transcatheter Edge-to-Edge Repair (TEER) DEVICE

TriClip System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Scripps Health

La Jolla, California, 92037, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Ospedale San Raffaele - Cardiac

Milan, Lombard, 20132, Italy

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Meghan Griffin

  Abbott

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 1, 2033
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IT (1)