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IRCT20210413050952N1 IRCT 2021-04-28 Dastavard-e-Sina Co. Evaluation of safety and efficacy of CardiaMed heart valve prosthesis in a multicentral study on patients undergoing open heart valve surgery Evaluation of safety and efficacy of CardiaMed heart valve prosthesis in a multicentral study on patients undergoing open heart valve surgery 2021-05-22 anticipated 100 Complete https://irct.ir/trial/55754 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient selection will be performed based on inclusion and exclusion criteria. Each center will use simple randomization to enroll patients. The randomization will be based on stratified randomization so that either of centers will randomly enroll patients into study groups, including CardiaMed valve and St Jude valve. The stratification of sample size will be based on the centers’ surgery volume so that Rajaie will enroll 60 patients and two other centers will enroll rest of cases, 20 patients in each center. The randomization method will be as simple randomization. All patients will be marked using a table of random numbers. The assignment of patients into three centers will be randomly done from number 0 to 100 so that 60, 20, and 20 patients will be randomly assigned into three centers, respectively. Then, each center will enroll assigned patients into two groups. N/A Rheumatic heart disease. Intervention 1: Intervention group: CardiaMed mechanical valve - In this group a CardiaMed mechanical valve (CardiaMed; Penza, Russia) will be implemented via an open heart surgery in the mitral valve position. During a general anesthesia, the rheumatic mitral valve will be excised during open surgery and the CardiaMed mechanical valve will be implanted instead. Intervention 2: Control group: St Jude mechanical valve - In this group a St Jude mechanical valve (St. Jude Medical, Inc., St. Paul, Minn) will be implemented via an open heart surgery in the mitral valve position. During a general anesthesia, the rheumatic mitral valve will be excised during open surgery and the St Jude mechanical valve will be implanted instead. Yes - There is a plan to make this available What will be shared: After making data anonymous, it can be shared. When: At least, one year after study publication To whom: With researchers in the similar field via corresponding author after obtaining permission from ethics committee of main study center Conditions: Only for meta-analysis studies Where to obtain: Contact with corresponding author How to obtain: Contact with corresponding author and after obtaining permission from ethics committee of main study center Comments: None
public Gholamreza Omrani
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-sections
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 3061 omrani@rhc.ac.ir Iran University of Medical Sciences scientific Gholamreza Omrani
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-sections
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 2135 omrani@rhc.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Candidate for mechanical valve replacement due to rheumatic heart valve disease Isolated mitral valve replacement 16 years 65 years Both 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 I01 Rheumatic fever with heart involvement Treatment - Surgery Treatment - Surgery Intervention group: CardiaMed mechanical valve - In this group a CardiaMed mechanical valve (CardiaMed; Penza, Russia) will be implemented via an open heart surgery in the mitral valve position. During a general anesthesia, the rheumatic mitral valve will be excised during open surgery and the CardiaMed mechanical valve will be implanted instead. Control group: St Jude mechanical valve - In this group a St Jude mechanical valve (St. Jude Medical, Inc., St. Paul, Minn) will be implemented via an open heart surgery in the mitral valve position. During a general anesthesia, the rheumatic mitral valve will be excised during open surgery and the St Jude mechanical valve will be implanted instead. Valvular function. Timepoint: Preoperative, Early postoperative, 6 months postoperative, 1 year postoperative. Method of measurement: Echocardiography. 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. Dastavard-e-Sina Co. Approved 2019-10-26 Rajaie Cardiovascular Medical and Research Center No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-section, Tehran Tehran Iran (Islamic Republic of)