Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein

Pulmonary Embolism Clinical Trial

Official title:

Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02430207
• Other study ID #: KFSN201407
• Status: Not yet recruiting
• Phase: N/A
• First received: April 21, 2015
• Last updated: February 18, 2016
• Start date: May 2015

Study information

• Verified date: April 2015
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Kai Gu, M.D.
• Phone: 0086 25 68136965
• Email: gukaiwang[@]163.com
• Is FDA regulated: No
• Health authority: China: Jiangsu provincial health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or older

• There is indication for temporary pacing

• Patients agreed to participate in the clinical trial and sign a written informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Procedure:
• temporary pacing femoral vein
Temporary pacing via femoral or subclavian vein
• temporary pacing subclavian vein

Locations

Country	Name	City	State
n/a

Sponsors (16)

Lead Sponsor

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Changzhou No.2 People's Hospital, Danyang People's Hospital of Jiangsu Province, Jiangsu Province Hospital of Traditional Chinese Medicine, Jiangsu Taizhou People's Hospital, Jiangyin People's Hospital, Nantong No. 1 People's Hospital, Qidong People's Hospital, Rugao People's Hospital, Suqian People's Hospital, The First people's Hospital of Kunshan, The Northern Jiangsu People's Hospital, Wuxi No. 2 People's Hospital, Xinghua People's Hospital, Xuzhou Central Hospital, Xuzhou Medical College

References & Publications (10)

Cheng TO. Percutaneous transfemoral venous cardiac pacing. A simple and practical method. Chest. 1971 Jul;60(1):73-8. — View Citation

FURMAN S, SCHWEDEL JB. An intracardiac pacemaker for Stokes-Adams seizures. N Engl J Med. 1959 Nov 5;261:943-8. — View Citation

Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. Review. — View Citation

Klatsky 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. — View Citation

López Ayerbe J, Villuendas Sabaté R, García García C, Rodríguez Leor O, Gómez Pérez M, Curós 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. — View Citation

Nolewajka AJ, Goddard MD, Brown TC. Temporary transvenous pacing and femoral vein thrombosis. Circulation. 1980 Sep;62(3):646-50. — View Citation

Pandian NG, Kosowsky BD, Gurewich V. Transfemoral temporary pacing and deep vein thrombosis. Am Heart J. 1980 Dec;100(6 Pt 1):847-51. — View Citation

Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galiè 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. — View Citation

Weinstein 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. — View Citation

ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric stimulation. N Engl J Med. 1952 Nov 13;247(20):768-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants suffering from pulmonary embolism		12 hours to 7 days after extraction of temporary pacing leads	Yes
Secondary	Percentage of participants suffering from deep vein thrombosis		12 hours to 7 days after extraction of temporary pacing leads	Yes