Specific Aim 1: The evaluation of safety and efficacy of CardiaMed prosthetic valve in Iranian patients undergoing open heart valve surgery
Specific Aim 2: To compare the outcomes of patients with CardiaMed valves with those of patients with other mechanical valves
Design
Patients who are candidate for open heart valve surgery will be evaluated. First, patients will be informed about the details and features of CardiaMed valve. Then, after giving information to the patients, they will be requested to give consent for the implementation of CardiaMed valve, otherwise they will be implemented other mechanical valves. The randomization will be based on stratified randomization so that either of centers will randomly enroll patients into the study groups. The stratification of sample size will be based on either of centers’ surgery volume so that Rajaie will enroll 60 patents and two other centers will enroll rest of cases, 20 patients in each center.
Settings and conduct
All patients will be selected from 3 centers in Iran, including Rajaie hospital, Hazrat Rasoul Hospital of Tehran, and Dena hospital of Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patients aged 16-65 years old
2) Candidate for mechanical valve replacement due to rheumatic heart valve disease
3) Isolated mitral valve replacement
Exclusion criteria:
1) Patients undergoing re-do surgeries
2) Patients with left ventricular ejection fraction ≤35%
3) Concomitant coronary artery bypasses graft surgery
4) Concomitant other valve surgeries (i.e. valvular repair)
5) Patients suspicious for native valve endocarditis
6) Patients with contraindicated warfarin consumption
Intervention groups
CardiaMed valve prosthesis
Other mechanical valve
Main outcome variables
Valvular function
Bleeding
Re-operation rates
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210413050952N1
Registration date:2021-04-28, 1400/02/08
Registration timing:prospective
Last update:2021-04-28, 1400/02/08
Update count:0
Registration date
2021-04-28, 1400/02/08
Registrant information
Name
Gholamreza Omrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2135
Email address
omrani@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of CardiaMed heart valve prosthesis in a multicentral study on patients undergoing open heart valve surgery
Public title
Evaluation of safety and efficacy of CardiaMed heart valve prosthesis in a multicentral study on patients undergoing open heart valve surgery
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rajaie Cardiovascular Medical and Research Center
Street address
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-section,
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.RHC.REC.1400.001
Health conditions studied
1
Description of health condition studied
Rheumatic heart disease
ICD-10 code
I01
ICD-10 code description
Rheumatic fever with heart involvement
Primary outcomes
1
Description
Valvular function
Timepoint
Preoperative, Early postoperative, 6 months postoperative, 1 year postoperative
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Bleeding
Timepoint
Postoperative and 1 year after surgery
Method of measurement
Physical examination and checking INR
2
Description
Heart valve re-operation
Timepoint
Postoperative and 1 year after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Gholamreza Omrani
Street address
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-sections
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
info@rhc.ac.ir
Web page address
http://rhc.ac.ir/
2
Recruitment center
Name of recruitment center
Dena Hospital
Full name of responsible person
Ahmad Ali Amir Ghofran
Street address
No1, Bolvar-e-Sattar Khan, Shiraz
City
Shiraz
Province
Fars
Postal code
71955967
Phone
+98 71 3649 0411
Fax
+98 71 3649 0433
Email
info@denahospital.com
Web page address
http://www.denahospital.com/
3
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Medical Center
Full name of responsible person
Sam Zeraatian Nejad
Street address
No 1, Niayesh St, Sattar Khan st, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1123
Fax
+98 21 6650 2248
Email
hrmc@iums.ac.ir
Web page address
https://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dastavard-e-Sina Co.
Full name of responsible person
Mohammad Samiani
Street address
No52, Darya Blvd , Sa'adat Abad , Tehran
City
Tehran
Province
Tehran
Postal code
1466983577
Phone
+98 21 8808 6389
Fax
+98 21 8836 9769
Email
info@dastavardesina.com
Web page address
https://www.dastavardesina.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dastavard-e-Sina Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Omrani
Position
Assoc. Prof
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-sections
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3061
Fax
+98 21 2266 3209
Email
omrani@rhc.ac.ir
Web page address
http://rhc.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Omrani
Position
Assoc. Prof
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-sections
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2135
Fax
Email
omrani@rhc.ac.ir
Web page address
http://rhc.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Omrani
Position
Assoc. Prof
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No 1, Rajaie CMRC, Hashemi Rafsanjani Highway and Vali-e-Asr St. cross-sections
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2135
Fax
Email
omrani@rhc.ac.ir
Web page address
http://rhc.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After making data anonymous, it can be shared.
When the data will become available and for how long
At least, one year after study publication
To whom data/document is available
With researchers in the similar field via corresponding author after obtaining permission from ethics committee of main study center
Under which criteria data/document could be used
Only for meta-analysis studies
From where data/document is obtainable
Contact with corresponding author
What processes are involved for a request to access data/document
Contact with corresponding author and after obtaining permission from ethics committee of main study center