Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Trial details

Who runs it

Foldax, Inc

Trial code

NCT03851068

Record updated

13 September 2023

Original description

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.Read full original descriptionShow less

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Inclusion: Is 18 years or older; Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement; Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial; Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations.

Exclusion: Requires emergency surgery; Has had prior valve surgery; Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device; Has active endocarditis/myocarditis or within 3 months to the scheduled surgery; Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery; Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery; Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery; Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery; Has prior organ transplant or is currently an organ transplant candidate; Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial; Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant; Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump; Requires a surgical procedure outside of the cardiac area; Requires a cardiac procedure other than a CABG or root enlargement; Echocardiographic evidence of an intra-cardiac thrombus or vegetation; Tests positive for an active infection with SARS-CoV-2 (COVID-19); Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit; Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism; Echocardiographic left ventricular ejection fraction <25%; Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy; Requires multiple valve replacement / repair; Has life expectancy to less than 12 months; Pregnant, lactating or planning to become pregnant during the duration of participation in trial; Currently incarcerated or unable to give voluntary informed consent.

ClinicalTrials.gov NCT03851068