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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT06191718
Eligibility Criteria:
Inclusion Criteria:
* Is 18 years or older
* Is a candidate for mitral valve replacement with cardiopulmonary bypass
* Is a candidate for mitral valve replacement due to severe mitral valve disease
* No contraindication for anticoagulation treatment
* Willing and able to comply with protocol requirements
Exclusion Criteria:
* Requires valve replacement other than mitral
* Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
* Required concomitant cardiovascular procedures except for CABG and/or COX-MAZE if approved by the screening committee
* Requires emergency surgery
* Requires other planned surgery within 12 months of valve replacement
* Active endocarditis or active myocarditis
* Exhibits left ventricular ejection fraction \</= 20% as validated by diagnostic procedure prior to planned valve surgery
* Acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment
* Life expectancy of less than 12 months
* Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies)
* Myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment
* Aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications
* Renal insufficiency as determined by creatinine (S-CR) level as \>/= 2.0 mg/dl or end stage renal disease requiring chronic dialysis at screening visit
* Results for the following blood tests are not within normal limits: D-Dimer, Basic Metabolic Panel Liver enzymes, Coagulation Profile - platelets, APTT, INR, Fibrinogen, C-reactive protein (HSCRP) and ESR, and Troponin levels
* Hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dL, platelet count of \<100,000 cells/µL, or WBC \<4,000 cells/µL; coagulation profile must not be outside of normal limits
* Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating
* Any other condition that, in the judgment of the investigator and screening committee, makes the patient a poor candidate for the procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, COVID-19 related concerns)
* Patients who have withdrawn after implantation may not re-enter
* Intraoperatively it is determined that the patient anatomy is not compatible with the device.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06191718
Study Brief:
Protocol Section:
NCT06191718