Innoventric Trilliumâ„¢ Stent Graft First-in-Human (FIH) Study
Belgium, Germany20 participantsStarted 2020-06-24
Plain-language summary
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trilliumâ„¢ Stent Graft System.
Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \>40 (no upper limit)
✓. Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm\^2
✓. Symptomatic despite medical therapy; patient must be on diuretic therapy.
✓. Peak central venous pressure of ≥ 15mmHg
✓. The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
✓. Patient is willing and able to comply with all specified study evaluations.
✓. Patient has NYHA functional classification of III or IV
✓. Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
Exclusion criteria
✕. Echocardiographic parameters (Any of the following):
✕. Systolic Pulmonary Artery Pressure \> 70mmHg
✕. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
✕. Active endocarditis within 90 days of the scheduled implant
✕
What they're measuring
1
Safety Endpoint
Timeframe: Evaluated immediately after intervention, discharge and 30 days
2
Technical performance
Timeframe: Evaluated immediately after intervention
3
Efficacy Endpoint
Timeframe: Evaluated immediately after intervention