Clinical Investigation for the PoliaValve Aortic Heart Valve- India

NCT07123766 | Not Yet Recruiting

• 1 other identifier: PoliaValve-SA-03
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

AORTIC VALVE DISEASES; Aortic Valve Stenosis; Aortic Valve Regurgitation

Keywords

Heart Valve Diseases; Aortic Valve Regurgitation; Aortic Valve Disease; Polymeric Aortic Valve

Outcome Measures

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

  12 months following patient enrollment completion

Secondary Outcomes (11)

• Effective Orifice Area (EOA)

  12 months following patient enrollment completion

• Mean Pressure Gradient(MPG)

  12 months following patient enrollment completion

• New York Heart Association(NYHA) Improvement Assessment

  12 months following patient enrollment completion

• Rate of Stroke

  12 months following patient enrollment completion

• Rate of Transient Ischemic Attack(TIA)

  12 months following patient enrollment completion

Study Arms (1)

Experimental group(PoliaValve)

EXPERIMENTAL

Patients receiving the PoliaValve (Aortic) from HearrHill Medical

Device: PoliaValve (Aortic)

Interventions

PoliaValve (Aortic) DEVICE

Aortic Valve Replacement

Experimental group(PoliaValve)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Hearthill Medical Technology Co.,LTD: lead

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Kevin Yan

CONTACT

(+86)021-68248839; kevin.yan@hearthillmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 14, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share