Comparison of left ventricle segments contraction pattern by echocardiography in Right ventricular apical pacing with Right ventricular septal pacing in patient with complete heart block in Tabriz Shahid Madani hospital.
Objectives: The aim of this study is comparsion of new pacemaker implantation method with traditional method.
Design: This study is a randomised clinical trial with control group.
Setting and condct: Sixty patients with symptomatic bradycardia and left ventricular ejection fraction more than 50% which candidates for permanent pacemaker placement will be enrolled the survey. Patients will be divided into two groups randomly which pacemaker lead will be implanted at right ventricle apex in one group and for another group it will be implanted in septum. All patients will be studied six months later by echocardiography and the results of these two groups will be compared.
Participants including major eligibility criteria: The major inclusion criteria is patients with symptomatic bradycardia and complete heart block with left ventricular ejection fraction more than 50% that candidate for permanent pacemaker and the major exclusion criteria will be consist of symptomatic coronary artery disease;
Apparent valvular heart disease; Cardiomyopathy and left venticular ejection fraction less than 50% before pacemaker implantation.
Intervention: Eligible patients will be divided into two groups randomly which pacemaker lead will be implanted at right ventricle apex in one group and for another group it will be implanted in septum.
Main outcome: The primery outcome is evaluation of left ventricle segments contraction pattern in new method in comparsion of traditional pacemaker implantation method that will be done by echocardiography 6 month after pacemaker implantation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012216314N1
Registration date:2014-07-03, 1393/04/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-03, 1393/04/12
Registrant information
Name
Kamran Mohammadi
Name of organization / entity
Tabriz Medical University
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 6072
Email address
mohammadik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2014-07-06, 1393/04/15
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of left ventricle segments contraction pattern by echocardiography in Right ventricular apical pacing with Right ventricular septal pacing in patient with complete heart block in Tabriz Shahid Madani hospital.
Public title
Comparsion of results between traditional and new pacemaker implantation methods.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with symptomatic bradycardia and complete heart block with left ventricular ejection fraction that candidate for permanent pacemaker.
Exclusion criteria: Symptomatic coronary artery disease; Apparent valvular heart disease; Cardiomyopathy; Left ventricular ejection fraction less than 50% before pacemaker implantation.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz Medical University ethic committee
Street address
Number 14, Ethic committee, Tabriz Medical University Central building, Golgasht street, Azadi street, Tabriz.
City
Tabriz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
92153
Health conditions studied
1
Description of health condition studied
Complete atrioventricular block
ICD-10 code
I44.2
ICD-10 code description
Complete heart block NOSThird-degree block
Primary outcomes
1
Description
Amount of different segments contraction of LV
Timepoint
6 month after intervention
Method of measurement
With speckle tracking echocardiography
Secondary outcomes
1
Description
Left ventricle ejection fraction
Timepoint
6 month after pace maker implantation
Method of measurement
With echocardiography
Intervention groups
1
Description
Control group:
In the control group pacemaker will be implanted subcutaneously by a 10cm section in the left hemi thorax. In this group the Pacemaker leads will be implanted in right ventricular apex.
Category
Treatment - Surgery
2
Description
Intervention Group:
In the interventional group pacemaker will be implanted subcutaneously by a 10cm section in the left hemi thorax. In this group the Pacemaker leads will be implanted in right ventricular septum.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Shahid Madani hospital
Full name of responsible person
Kamran Mohammadi resident of cardiology
Street address
Number 12, Shahid Madani hospital, Daneshgah street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Research committee assistant, Dr Shahsar.
Street address
Number 14, Tabriz Medical University Central building, Golgasht street, Azadi Street, Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz Medical University
Full name of responsible person
Kamran Mohammadi
Position
Rezidence of cardiology
Other areas of specialty/work
Street address
Number 12, Shahid Madani hospital, Daneshgah street, Tabriz.