Clinical Investigation for the Foldax Tria Aortic Heart Valve- India

Foldax

Status

Active, not recruiting

Conditions

Aortic Valve Stenosis

Aortic Valve Disease

Aortic Valve Insufficiency

Aortic Valve Calcification

Treatments

Device: Foldax Tria Aortic Valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT06192706

Foldax CP-003

Details and patient eligibility

About

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.

Full description

The Foldax Tria Aortic Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. These patients will follow the study schedule for 1 year after implantation.

Enrollment

50 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Is 45 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 1 year 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 criteria

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)
Currently diagnosed as uncontrolled diabetes mellitus (Random BLS > 300 mg/dl)