Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
NCT ID: NCT03860090
Last Updated: 2019-03-01
Study Results
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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UNKNOWN
NA
240 participants
INTERVENTIONAL
2017-10-01
2022-10-31
Brief Summary
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Half of participants will receive the implant via fluoroscopy guided axillary venous access and the other half will receive the implant via improved cephalic venous access.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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AXILLARY VEIN ACCESS
This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique.
Pacemaker implant
Implantation of endovenous cardiac stimulation device.
Defibrillator implant
Implantation of endovenous cardiac defibrillation device.
AXILLARY VEIN ACCESS
Fluoroscopy-guided axillary puncture to get vein access
CEPHALIC VEIN ACCESS
This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique.
Pacemaker implant
Implantation of endovenous cardiac stimulation device.
Defibrillator implant
Implantation of endovenous cardiac defibrillation device.
CEPHALIC VEIN ACCESS
Optimized cephalic vein cutdown to get vein access
Interventions
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Pacemaker implant
Implantation of endovenous cardiac stimulation device.
Defibrillator implant
Implantation of endovenous cardiac defibrillation device.
AXILLARY VEIN ACCESS
Fluoroscopy-guided axillary puncture to get vein access
CEPHALIC VEIN ACCESS
Optimized cephalic vein cutdown to get vein access
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous ipsilateral lymphadenectomy.
* Indication of cardiac resynchronization therapy.
18 Years
ALL
No
Sponsors
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Castilla-La Mancha Health Service
OTHER
Responsible Party
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Principal Investigators
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Javier Jiménez Díaz, Dr.
Role: PRINCIPAL_INVESTIGATOR
Arrhythmia Unit Director
Locations
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Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Countries
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References
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Calkins H, Ramza BM, Brinker J, Atiga W, Donahue K, Nsah E, Taylor E, Halperin H, Lawrence JH, Tomaselli G, Berger RD. Prospective randomized comparison of the safety and effectiveness of placement of endocardial pacemaker and defibrillator leads using the extrathoracic subclavian vein guided by contrast venography versus the cephalic approach. Pacing Clin Electrophysiol. 2001 Apr;24(4 Pt 1):456-64. doi: 10.1046/j.1460-9592.2001.00456.x.
Squara F, Tomi J, Scarlatti D, Theodore G, Moceri P, Ferrari E. Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access. Europace. 2017 Dec 1;19(12):2001-2006. doi: 10.1093/europace/euw363.
Jimenez-Diaz J, Higuera-Sobrino F, Piqueras-Flores J, Perez-Diaz P, Gonzalez-Marin MA. Fluoroscopy-guided axillary vein access vs cephalic vein access in pacemaker and defibrillator implantation: Randomized clinical trial of efficacy and safety. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1588-1593. doi: 10.1111/jce.14060. Epub 2019 Jul 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A-276
Identifier Type: -
Identifier Source: org_study_id
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