Evaluation of safety and efficacy of CardiaMed heart valve prosthesis in a multicentral study on patients undergoing open heart valve surgery
Not Applicable
Recruiting
- Conditions
- Rheumatic heart disease.Rheumatic fever with heart involvement
- Registration Number
- IRCT20210413050952N1
- Lead Sponsor
- Dastavard-e-Sina Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Candidate for mechanical valve replacement due to rheumatic heart valve disease
Isolated mitral valve replacement
Exclusion Criteria
Patients undergoing re-do surgeries
Patients with left ventricular ejection fraction =35%
Concomitant coronary artery bypasses graft surgery
Concomitant other valve surgeries
Patients suspicious for native valve endocarditis
Patients with contraindicated warfarin consumption
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Valvular function. Timepoint: Preoperative, Early postoperative, 6 months postoperative, 1 year postoperative. Method of measurement: Echocardiography.
- Secondary Outcome Measures
Name Time Method Bleeding. Timepoint: Postoperative and 1 year after surgery. Method of measurement: Physical examination and checking INR.;Heart valve re-operation. Timepoint: Postoperative and 1 year after surgery. Method of measurement: Physical examination.