Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein
Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China
1 other identifier
interventional
360
0 countries
N/A
Brief Summary
Temporary pacing via femoral vein is used widely in mainland China, because of its feasibility and simplicity. However, pulmonary embolism often occurred after the procedure. It is not known that whether there was any difference in incidence of pulmonary embolism between via different approaches. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 30, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedFebruary 19, 2016
April 1, 2015
1 year
April 21, 2015
February 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants suffering from pulmonary embolism
12 hours to 7 days after extraction of temporary pacing leads
Secondary Outcomes (1)
Percentage of participants suffering from deep vein thrombosis
12 hours to 7 days after extraction of temporary pacing leads
Study Arms (2)
Femoral Vein
EXPERIMENTALpatients receiving temporary pacing via femoral vein
Subclavian Vein
EXPERIMENTALpatients receiving temporary pacing via subclavian vein
Interventions
Eligibility Criteria
You may qualify if:
- years old or older
- There is indication for temporary pacing
- Patients agreed to participate in the clinical trial and sign a written informed consent
You may not qualify if:
- History of pulmonary embolism or deep vein thrombosis
- Devices existing in vein system
- Patients who could not receive randomization
- Severe coagulation disorder
- Severe liver, kidney dysfunction
- Mental diseases
- Pregnancy
- Patients investigators believed not suitable for enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital with Nanjing Medical Universitylead
- Suqian People's Hospitalcollaborator
- The First People's Hospital of Kunshancollaborator
- Danyang People's Hospital of Jiangsu Provincecollaborator
- Jiangsu Taizhou People's Hospitalcollaborator
- Xinghua People's Hospitalcollaborator
- Jiangyin People's Hospitalcollaborator
- Qidong People's Hospitalcollaborator
- Wuxi No. 2 People's Hospitalcollaborator
- Nantong No. 1 People's Hospitalcollaborator
- Changzhou No.2 People's Hospitalcollaborator
- Xuzhou Medical Universitycollaborator
- Jiangsu Province Hospital of Traditional Chinese Medicinecollaborator
- Northern Jiangsu People's Hospitalcollaborator
- Rugao People's Hospitalcollaborator
- Xuzhou Central Hospitalcollaborator
Related Publications (10)
ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric stimulation. N Engl J Med. 1952 Nov 13;247(20):768-71. doi: 10.1056/NEJM195211132472005. No abstract available.
PMID: 13002611BACKGROUNDGammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.
PMID: 10814641BACKGROUNDFURMAN S, SCHWEDEL JB. An intracardiac pacemaker for Stokes-Adams seizures. N Engl J Med. 1959 Nov 5;261:943-8. doi: 10.1056/NEJM195911052611904. No abstract available.
PMID: 13825713BACKGROUNDCheng TO. Percutaneous transfemoral venous cardiac pacing. A simple and practical method. Chest. 1971 Jul;60(1):73-8. doi: 10.1378/chest.60.1.73. No abstract available.
PMID: 5571275BACKGROUNDWeinstein J, Gnoj J, Mazzara JT, Ayres SM, Grace WJ. Temporary transvenous pacing via the percutaneous femoral vein approach. A prospective study of 100 cases. Am Heart J. 1973 May;85(5):695-705. doi: 10.1016/0002-8703(73)90178-6. No abstract available.
PMID: 4697639BACKGROUNDPandian NG, Kosowsky BD, Gurewich V. Transfemoral temporary pacing and deep vein thrombosis. Am Heart J. 1980 Dec;100(6 Pt 1):847-51. doi: 10.1016/0002-8703(80)90065-4.
PMID: 7446387BACKGROUNDNolewajka AJ, Goddard MD, Brown TC. Temporary transvenous pacing and femoral vein thrombosis. Circulation. 1980 Sep;62(3):646-50. doi: 10.1161/01.cir.62.3.646.
PMID: 7398027BACKGROUNDLopez Ayerbe J, Villuendas Sabate R, Garcia Garcia C, Rodriguez Leor O, Gomez Perez M, Curos Abadal A, Serra Flores J, Larrousse E, Valle V. [Temporary pacemakers: current use and complications]. Rev Esp Cardiol. 2004 Nov;57(11):1045-52. Spanish.
PMID: 15544753BACKGROUNDKlatsky AL, Armstrong MA, Poggi J. Risk of pulmonary embolism and/or deep venous thrombosis in Asian-Americans. Am J Cardiol. 2000 Jun 1;85(11):1334-7. doi: 10.1016/s0002-9149(00)00766-9.
PMID: 10831950BACKGROUNDTorbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.
PMID: 18757870BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minglong Chen, M.D.
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University
Study Record Dates
First Submitted
April 21, 2015
First Posted
April 30, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2016
Last Updated
February 19, 2016
Record last verified: 2015-04