Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT07123766
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT07123766
Study Brief:
Protocol Section:
NCT07123766