A Post-Market Assessment of the Safety and Performance of the TriClip™ System
ConditionTricuspid Regurgitation (TR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
DeviceTriClip System
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Through 30 days post-procedure2
Tricuspid Regurgitation (TR) grade less than or equal to moderate
Time frame
At 30-day follow-up3
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.
Time frame
At 30-day follow-upSponsors and contacts
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Source ClinicalTrials.gov