Recruiting

TriClip System

Sponsor:

Abbott Medical Devices

Code:

NCT07586995

Conditions

Tricuspid Regurgitation (TR)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tricuspid Transcatheter Edge-to-Edge Repair (TEER)

Study Details

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)

Study ID

NCT07586995

Start date

Jul 2, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2033

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Tricuspid Transcatheter Edge-to-Edge Repair (TEER)

TriClip System

Primary outcome measure

  • Rate of Peri-Procedural Adverse Events [ Time Frame: Through 30 days post-procedure ]
  • Tricuspid Regurgitation (TR) grade less than or equal to moderate [ Time Frame: At 30-day follow-up ]
  • Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points [ Time Frame: At 30-day follow-up ]

Central Contacts and Locations

Central contacts

Allison Wood

612-518-9034allison.wood@abbott.com

Jennifer Studt

314-616-2790jennifer.studt@abbott.com

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Maggie McNamara

312-926-0846margaret.mcnamara@nm.org

Principal Investigator:

Akhil Narang, MD

Ascension Texas Cardiovascular Research

Recruiting

Austin, Texas, United States, 78705

Contacts

Abigail Alvarado

979-571-0577abigail.alvarado@ascension.org

Principal Investigator:

Mark Gajjar, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Sep 2, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-09-02.