Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)

Complication Clinical Trial

— CEPHAX  

Official title:

Prospective Randomized Comparison of Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access. The CEPHAX Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03860090
• Other study ID #: A-276
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 2022

Study information

• Verified date: February 2019
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: October 2022
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Defibrillators
• Pacemaker Electrode Lead Fracture
• Pacemakers

Intervention

Device:
• Pacemaker implant
Implantation of endovenous cardiac stimulation device.
• Defibrillator implant
Implantation of endovenous cardiac defibrillation device.

Procedure:
• AXILLARY VEIN ACCESS
Fluoroscopy-guided axillary puncture to get vein access
• CEPHALIC VEIN ACCESS
Optimized cephalic vein cutdown to get vein access

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to access.	Time until reaching venous access.	From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes.
Other	Time of implant.	Intervention time.	From the skin incision to the skin suture, assessed up to 180 minutes.
Primary	Implant Success	Success of the implant through the assigned access vein	30 days
Primary	Implant Complications	All implant related complications	30 days
Secondary	Lead Complications	Lead fracture or dysfunction	From date of implant until the date of first documented, assessed up to 48 months
Secondary	Upper limb thrombosis	Thrombosis of the ipsilateral upper limb	From date of implant until the date of first documented, assessed up to 48 months
Secondary	Pneumothorax	Implant related pneumothorax	30 days
Secondary	Bleeding	Implant related bleeding	30 days