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
Qualifiers
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
Treatments tested in this trial
- PoliaValve (Aortic)
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov