Trisol System EFS Study
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrisol Medical
About this trial
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
Eligibility criteria
Qualifiers
Age >18 years.
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
New York Heart Association (NYHA) Functional Class II to IVa.
Disqualifiers
Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
Stroke or transient ischemic event within the previous 90 days.
Acute myocardial infarction within the previous 90 days.
Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
Trial design
Treatments tested in this trial
- Transcatheter Tricuspid Valve Replacement
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov