Clinical Investigation for the PoliaValve Aortic Heart Valve- India
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorSuzhou Hearthill Medical Technology Co.,LTD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Requires multiple valve replacement / repair
Requires emergency surgery
Has had prior valve surgery
Requires a surgical procedure outside of the cardiac area
Trial design
Design model
Single group
Treatments tested in this trial
PoliaValve (Aortic)
DeviceAortic Valve Replacement
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Experimental group(PoliaValve)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Clinical Outcomes Events
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
Time frame
12 months following patient enrollment completionSecondary outcomes
1
Effective Orifice Area (EOA)
Using doppler echocardiography to Measure Effective Orifice Area (EOA)
Time frame
12 months following patient enrollment completion2
Mean Pressure Gradient(MPG)
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.
Time frame
12 months following patient enrollment completion3
New York Heart Association(NYHA) Improvement Assessment
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.
Time frame
12 months following patient enrollment completion4
Rate of Stroke
Assessment of patient experiencing a stroke verified by imaging and or physical exam
Time frame
12 months following patient enrollment completionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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