NCT07586995 · Abbott Medical Devices
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
(TREAT TR)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
TriClip System
Primary outcome measures
Rate of Peri-Procedural Adverse Events
Time frame: Through 30 days post-procedure
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
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
All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- La Jolla, California
- Chicago, Illinois
- Elk Grove, Illinois
- New York, New York
- Austin, Texas
- Houston, Texas
- Norfolk, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 6, 2026 · Source of record for eligibility and locations