Clinical trial NCT03860090: Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
Official title: Prospective Randomized Comparison of Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access. The CEPHAX Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemakers
Defibrillators
Complication
Pacemaker Electrode Lead Fracture
Keywords: Cephalic Vein
Axillary Vein
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial evaluates the efficacy and safety of axillary versus cephalic venous access in the pacemakers and defibrillators implantation.

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.


Eligibility criteria: Inclusion Criteria:

* Patients with a endovenous pacemaker or defibrillator indication.

Exclusion Criteria:

* Pre-existing ipsilateral pacing electrode.
* Previous ipsilateral lymphadenectomy.
* Indication of cardiac resynchronization therapy.

Primary outcomes:
measure: Implant Success
timeFrame: 30 days
measure: Implant Complications
timeFrame: 30 days
Secondary outcomes:
measure: Lead Complications
timeFrame: From date of implant until the date of first documented, assessed up to 48 months
measure: Upper limb thrombosis
timeFrame: From date of implant until the date of first documented, assessed up to 48 months
measure: Pneumothorax
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
Other outcomes:
measure: Time to access.
timeFrame: From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes.
measure: Time of implant.
timeFrame: From the skin incision to the skin suture, assessed up to 180 minutes.
Locations:
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
Study officials:
affiliation: Arrhythmia Unit Director
name: Javier Jiménez Díaz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.