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

NCT ID: NCT02430207

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Femoral Vein

patients receiving temporary pacing via femoral vein

Group Type EXPERIMENTAL

temporary pacing femoral vein

Intervention Type PROCEDURE

Temporary pacing via femoral or subclavian vein

Subclavian Vein

patients receiving temporary pacing via subclavian vein

Group Type EXPERIMENTAL

temporary pacing subclavian vein

Intervention Type PROCEDURE

Interventions

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temporary pacing femoral vein

Temporary pacing via femoral or subclavian vein

Intervention Type PROCEDURE

temporary pacing subclavian vein

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suqian People's Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Kunshan

OTHER

Sponsor Role collaborator

Danyang People's Hospital of Jiangsu Province

UNKNOWN

Sponsor Role collaborator

Jiangsu Taizhou People's Hospital

OTHER

Sponsor Role collaborator

Xinghua People's Hospital

UNKNOWN

Sponsor Role collaborator

Jiangyin People's Hospital

OTHER

Sponsor Role collaborator

Qidong People's Hospital

UNKNOWN

Sponsor Role collaborator

Wuxi No. 2 People's Hospital

OTHER

Sponsor Role collaborator

Nantong No. 1 People's Hospital

UNKNOWN

Sponsor Role collaborator

Changzhou No.2 People's Hospital

OTHER

Sponsor Role collaborator

Xuzhou Medical University

OTHER

Sponsor Role collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Northern Jiangsu People's Hospital

OTHER

Sponsor Role collaborator

Rugao People's Hospital

OTHER

Sponsor Role collaborator

Xuzhou Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Minglong Chen

Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minglong Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

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Kai Gu, M.D.

Role: CONTACT

0086 25 68136965

References

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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.

Reference Type BACKGROUND
PMID: 13002611 (View on PubMed)

Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.

Reference Type BACKGROUND
PMID: 10814641 (View on PubMed)

FURMAN 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.

Reference Type BACKGROUND
PMID: 13825713 (View on PubMed)

Cheng 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.

Reference Type BACKGROUND
PMID: 5571275 (View on PubMed)

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. doi: 10.1016/0002-8703(73)90178-6. No abstract available.

Reference Type BACKGROUND
PMID: 4697639 (View on PubMed)

Pandian 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.

Reference Type BACKGROUND
PMID: 7446387 (View on PubMed)

Nolewajka 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.

Reference Type BACKGROUND
PMID: 7398027 (View on PubMed)

Lopez 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.

Reference Type BACKGROUND
PMID: 15544753 (View on PubMed)

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. doi: 10.1016/s0002-9149(00)00766-9.

Reference Type BACKGROUND
PMID: 10831950 (View on PubMed)

Torbicki 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.

Reference Type BACKGROUND
PMID: 18757870 (View on PubMed)

Other Identifiers

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KFSN201407

Identifier Type: -

Identifier Source: org_study_id

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