Not yet recruiting NCT07123766
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PoliaValve (Aortic).
- Who it may be relevant to
- Registry conditions: AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve
Overview
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
- Device PoliaValve (Aortic)
Aortic Valve Replacement
Primary outcome measures
- Rate of Clinical Outcomes Events [Time frame: 12 months following patient enrollment completion]
Secondary outcome measures (11)
- Effective Orifice Area (EOA) [Time frame: 12 months following patient enrollment completion]
- Mean Pressure Gradient(MPG) [Time frame: 12 months following patient enrollment completion]
- New York Heart Association(NYHA) Improvement Assessment [Time frame: 12 months following patient enrollment completion]
- Rate of Stroke [Time frame: 12 months following patient enrollment completion]
- Rate of Transient Ischemic Attack(TIA) [Time frame: 12 months following patient enrollment completion]
- Intensive Care Unit(ICU) Duration of Stay [Time frame: 30 days post procedure]
- Ventilation Time [Time frame: 30 days post procedure]
- Rate of New Onset Atrial Fibrillation [Time frame: 12 months post procedure]
- Length of Stay in Hospital [Time frame: 30 days post procedure]
- Readmission [Time frame: 30 days post procedure]
- Hemolysis screen [Time frame: 12 months post procedure]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07123766 · PoliaValve-SA-03