Clinical Investigation for the PoliaValve Aortic Heart Valve- India

A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve

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

The PoliaValve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single-arm, open 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.

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 clinical trial
• Diagnosed with severe symptomatic aortic valve stenosis and/or regurgitation

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 or aortic root replacement
• 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 end-stage 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 (AMI) 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
• Currently has uncontrolled infection
• Currently diagnosed as uncontrolled diabetes mellitus (Random BLS > 300 mg/dl)