In this study, thirty patients who are admitted to Emam Ali hospital and they need pacemaker with any reasons are studied. In this study, We compare important parameters of both of pacemakers that are rate, sense and out put. Actually temporary pacemaker model ev4543 is set as reference and standard device and clinical parameters of this device compare with clinical parameters of produced pacemaker.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062113730N1
Registration date:2013-08-13, 1392/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-13, 1392/05/22
Registrant information
Name
Yousef Darabi Moghadam
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 3077
Email address
y.darabi@tickums.org
Recruitment status
Recruitment complete
Funding source
vice-chancellery of research & technology affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of clinical parameters of produced temporary cardiac pacemaker with temporary cardiac pacemaker model ev4543
Public title
A comparative study of clinical parameters of produced temporary cardiac pacemaker with temporary cardiac pacemaker model ev4543
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients who are candidate for open heart surgery (CABG) and have age between 50-90 years old.
Exclusion criteria: tachycardia and unstable cardiac health condition,
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building no 2, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
/7/420/4608/پ
Health conditions studied
1
Description of health condition studied
Dependence on temporary pacemaker
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
senstivity threshold
Timepoint
15 minets for any device
Method of measurement
observation varibles on device
2
Description
Rate
Timepoint
15 minets for any device
Method of measurement
observation varibles on patient monitoring system and device
3
Description
out put threshold
Timepoint
15 minets for any device
Method of measurement
observation varibles on patient monitoring system and device
Secondary outcomes
empty
Intervention groups
1
Description
Clinical parameters of temporary pacemaker model EV4543 that include rate, sense, out put compare with clinical parameters of produced pacemaker on patient dependence on temporary pacemaker.(self-control patient study)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Cardiovascular Center
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research & Technology Affairs Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building no 2, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice – Chancellery of Research & Technology Affairs Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yousef Darabimoghadam
Position
Bachelor of biomedicla engineering
Other areas of specialty/work
Street address
Building no 2, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences