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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT03289104
Eligibility Criteria:
Inclusion Criteria:
* Patient age ≥ 18 years
* Scheduled cardiac surgery including coronary artery bypass grafting, aortic valve replacement, mitral valve replacement/repair, or ascending aorta replacement.
* Patient undergoing elective or urgent surgery
* Ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion Criteria:
* Patients undergoing emergent cardiac surgery
* Severe congestive heart failure (NYHA class III or IV) at enrollment
* Prior cardiac surgery
* Patients undergoing ventricular assist device insertion or heart transplantation
* Patients with a known metal allergy or allergy to ZIPFIX implant
* Patients who refuses consent
* Patients who are unable to follow post-operative instructions
* Prior history of significant bleeding that might be expected to recur with cardiac surgery
* Dementia with a mini mental status examination (MMSE) score of \< 20
* Extra cardiac illness that is expected to limit survival to less than 5 years
* Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal
* Concurrent enrollment in another clinical trial
* Geographic inaccessibility for follow-up visits required by the protocol
* Prisoners or institutionalized individuals
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03289104
Study Brief:
Protocol Section:
NCT03289104