AORTIC VALVE DISEASES, Aortic Valve Regurgitation, Aortic Valve Stenosis
Conditions
Keywords
Heart Valve Diseases, Aortic Valve Regurgitation, Aortic Valve Disease, Polymeric Aortic Valve
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPoliaValve (Aortic)
Aortic Valve Replacement
Sponsors
Suzhou Hearthill Medical Technology Co.,LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinical Outcomes Events | 12 months following patient enrollment completion | The rate of adverse events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature: a) thromboembolism, b) valve thrombosis, c) major paravalvular leak, d) major hemorrhage, e) endocarditis, f) all-caused death, g) valve related death, h) valve related reoperation, i) valve explant, j) hemorrhage, k) all-cause reoperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pressure Gradient(MPG) | 12 months following patient enrollment completion | The mean pressure gradient (MPG) is a measure of the average pressure difference across a valve or a specific area in a fluid system, often measured by transthoracic echocardiogram. |
| New York Heart Association(NYHA) Improvement Assessment | 12 months following patient enrollment completion | Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
| Rate of Stroke | 12 months following patient enrollment completion | Assessment of patient experiencing a stroke verified by imaging and or physical exam |
| Rate of Transient Ischemic Attack(TIA) | 12 months following patient enrollment completion | Assessment of patient having a transient ischemic attack(TIA) verified by imaging and or physical exam |
| Intensive Care Unit(ICU) Duration of Stay | 30 days post procedure | Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes. |
| Effective Orifice Area (EOA) | 12 months following patient enrollment completion | Using doppler echocardiography to Measure Effective Orifice Area (EOA) |
| Rate of New Onset Atrial Fibrillation | 12 months post procedure | — |
| Length of Stay in Hospital | 30 days post procedure | — |
| Readmission | 30 days post procedure | Patient readmission to the hospital post discharge measured by date/time |
| Hemolysis screen | 12 months post procedure | Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments |
| Ventilation Time | 30 days post procedure | Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes |
Contacts
Primary ContactKevin Yan
Outcome results
None listed