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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00554151
Eligibility Criteria:
Inclusion Criteria:
* Males or females aged greater or equal to 18 to less than or equal to age 75.
* Patients with indications to undergo mitral valve repair consistent with ACC/AHA recommendations; including greater or equal to 2+ regurgitation by pre-operative TEE or TTE assessment.
* Candidate for cardiopulmonary bypass.
* A Left Ventricular Ejection Fraction greater or equal to 40%.
* Able and willing to comply with all study requirements, including the required study follow-up visits.
* Able and willing to five consent and follow study instructions.
* Female patients of childbearing potential (not surgically sterilized or more than one year postmenopausal), with a negative pregnancy test (serum beta-hCG) within 24 hours prior to mitral valve surgery.
Exclusion Criteria:
* Any previous cardiac surgery.
* Any interventional cardiology procedure within six months prior to study to include all patients that have had a drug eluting stent (DES) implanted within 6 months.
* Evidence of an acute Myocardial Infarction (MI) within 7 days of the intended treatment with the investigational device.
* Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.
* Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
* Recent or evolving bacterial endocarditis or patients under current antibiotic therapy.
* Patients with ICD's.
* Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the placement of the device or concurrent medical condition with a life expectancy of less than 12 months.
* Patients who are immunocompromised or with autoimmune diseases.
* Patients suffering from renal insufficiency (Creatinine \>2.5 mg/dL) or patients with chronic renal failure undergoing dialysis.
* Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. sever chronic obstructive pulmonary disease, hepatic failure, immunosuppressive abnormalities, haematological abnormalities).
* Significant mitral annular calcification.
* Use of Coumadin, IIbIIIa inhibitors, Clopidigrel (Plavix) or other anti-coagulants within (5) five days prior to surgery.
* Participation in any study involving an investigational drug or device within the past month, or ongoing participation in a study with an investigational device.
* Intolerance or hypersensitivity to anaesthetics.
* Patients in whom transesophageal echo/Doppler is contraindicated.
* History of bleeding diathesis or coagulopathy.
* History of stroke within the prior 6 months
* Subjects to undergo concomitant cardiac repair or replacement other than CABG (less than or equal to 3 vessels) mitral annuloplasty, tricuspid valve repair and ablation therapy for correction of atrial fibrillation. Excluded concomitant procedures are: aortic valve replacement, LV remodeling, surgery and congenital repair.
* Patients with Euroscore \> 10.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00554151
Study Brief:
Protocol Section:
NCT00554151