RecruitingNot Applicable

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

United States, Italy, Spain1,000 participantsStarted 2026-07-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Peri-Procedural Adverse Events

Timeframe: Through 30 days post-procedure

Tricuspid Regurgitation (TR) grade less than or equal to moderate

Timeframe: At 30-day follow-up

Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points

Timeframe: At 30-day follow-up

Trial details

NCT IDNCT07586995

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-09

Contact for this trial

Allison Wood

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

View on ClinicalTrials.gov More Tricuspid Regurgitation (TR) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Rate of Peri-Procedural Adverse Events

Timeframe: Through 30 days post-procedure

Tricuspid Regurgitation (TR) grade less than or equal to moderate

Timeframe: At 30-day follow-up

Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points

Timeframe: At 30-day follow-up