Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Running, not enrolling · Not applicable

Conditions studied: Aortic Valve Disease, Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT03851068

Run by

Foldax, Inc

People needed

40

Starts

2019-06-18

Expected to finish

2026-12-01

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Requires multiple valve replacement / repair
• Requires emergency surgery
• Has had prior valve surgery
• Requires a surgical procedure outside of the cardiac area
• Requires a cardiac procedure other than a CABG or root enlargement
• 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 renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit
• 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
• Has life expectancy to less than 12 months
• Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
• Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
• Echocardiographic left ventricular ejection fraction <25%
• Echocardiographic evidence of an intra-cardiac thrombus or vegetation
• Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
• 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
• 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
• Pregnant, lactating or planning to become pregnant during the duration of participation in trial
• Currently incarcerated or unable to give voluntary informed consent
• 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
• Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Where it is running

• St. Vincent Hospital — Indianapolis, Indiana, United States
• Ascension Via Christi St. Francis Hospital — Wichita, Kansas, United States
• William Beaumont Hospital — Detroit, Michigan, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• OhioHealth Riverside — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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