A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorJiangsu Trulive Medical Co., Ltd
About this trial
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system
Eligibility criteria
Qualifiers
Age ≥65 years old.
The subject must be assessed by the local heart team as a high-risk patient ineligible for surgery and has been stabilized on optimal medical therapy (OMT)（The OMT is evaluated by the local heart team and comprises medications including diuretics with a treatment duration of no less than 30 days; no medication was newly initiated or discontinued within the preceding 2 weeks before treatment, any dose reduction did not exceed 50% of the original dose, and any dose escalation did not exceed 100% of the original dose.）.
Despite OMT per the local heart team, patient has signs of TR or symptoms fromTR，and TR graded as at least severe on a TTE(assessedby the 5-grade classification).
New York Heart Association (NYHA) Class III-IV.
Disqualifiers
Transesophageal echocardiography (TEE) is contraindicated or cannot be completed.
Pulmonary arterial systolic pressure (PASP) >60 mmHg by Dopplerechocardiogram (unless right heart catheterization [RHC] demonstrates PASP ≤60 mmHg).
Left ventricular ejection fraction (LVEF) ≤ 25%.
Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation requiring surgical intervention.
Trial design
Treatments tested in this trial
- TruGamma System
- Optimal medical therapy (OMT)
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov