Unique ID issued by UMIN | UMIN000015280 |
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Receipt number | R000017771 |
Scientific Title | Assessment of a novel ligation technique to reduce the hemorrhaging in two cardiac device leads implantation through same cephalic vein |
Date of disclosure of the study information | 2014/09/29 |
Last modified on | 2016/08/24 20:21:58 |
Assessment of a novel ligation technique to reduce the hemorrhaging in two cardiac device leads implantation through same cephalic vein
FIGURE8
Assessment of a novel ligation technique to reduce the hemorrhaging in two cardiac device leads implantation through same cephalic vein
FIGURE8
Japan |
Sick sinus syndrome, atrioventricular block, congestive heart failure, ventricular tachycardia, ventricular fibrillation, and othe diseases requiring cardiac implantable electric devices
Cardiology |
Others
NO
In order to investigate the ability of hemoatasis and the lead maneuveability after a novel ligation techinique in two leads implantation throught one cephalic vein.
Efficacy
The alteration of hemorrhaging after the ligation compared to preligation
1) The alteration of lead maneuvability after the ligation compared to preligation in each patient
2) Success of two leads implantation through same cephalic vein
3) Comparison of hemorraging against control group
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Maneuver |
A novel ligation technique is to be performed to establish hemostasis of the margin of the cephalic vein as long as two device leads can be introduced into same cephalic vein. The subjects is assigned to Group A.
A normal ligation technique is to be performed to establish hemostasis of the margin of the cephalic vein unless two device leads can be introduced into same cephalic vein. The subjects is assigned to Group B.
20 | years-old | <= |
Not applicable |
Male and Female
Subjects all meet the criteria showen below:
1) Those who receive cardiac implantable electric devices requiring more than one lead.
2) Adult patient
3) Those who give a written consent for the present study
1) Those who is not able to give a written consent
2) Patients who already received device lead implantation from the target cephalic vein
3) Other subjects whom responsible doctors assume inappropriate for the study
4) Patients whose hemoglobin concentration is lower than the normal limits defined by the hospital
30
1st name | |
Middle name | |
Last name | Marehiko Ueda |
Chiba University Hospital
Department of Cardiovascular Medicine
1-8-1 Inohana Chuoku Chibashi Chiba-pref. JAPAN
043-222-7171
zta10540@nifty.com
1st name | |
Middle name | |
Last name | Takatsugu Kajiyama |
Chiba University Graduate School of Medicine
Department of Cardiovascular Medicine
1-8-1 Inohana Chuoku Chibashi Chiba-pref. JAPAN
043-222-7171
tak4poincar@gmail.com
Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
None
Other
NO
千葉大学医学部付属病院
2014 | Year | 09 | Month | 29 | Day |
Unpublished
Twenty-two atients were involved and 15 was classified into Group A and othe 5 was assigned to Group B. The novel ligation method effectively reduced hemorhagging from the margin of cephalic vein containing two device leads.The amount of hemorrhaging-per-minute before and after ligation was significantly different (4.99 ml/min vs. 0.40 ml/min, p = 0.001). No complication derived from the ligation method was not observed. Maneuvability of leads after ligation was not impaired compared to that of preligation.
Completed
2014 | Year | 08 | Month | 27 | Day |
2014 | Year | 08 | Month | 29 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 31 | Day |
2014 | Year | 09 | Month | 29 | Day |
2016 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017771
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