NCT03860090

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

February 21, 2019

Last Update Submit

February 28, 2019

Conditions

PacemakersDefibrillatorsComplicationPacemaker Electrode Lead Fracture

Keywords

Cephalic VeinAxillary Vein

Outcome Measures

Primary Outcomes (2)

  • Implant Success

    Success of the implant through the assigned access vein

    30 days

  • Implant Complications

    All implant related complications

    30 days

Secondary Outcomes (4)

  • Lead Complications

    From date of implant until the date of first documented, assessed up to 48 months

  • Upper limb thrombosis

    From date of implant until the date of first documented, assessed up to 48 months

  • Pneumothorax

    30 days

  • Bleeding

    30 days

Other Outcomes (2)

  • Time to access.

    From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes.

  • Time of implant.

    From the skin incision to the skin suture, assessed up to 180 minutes.

Study Arms (2)

AXILLARY VEIN ACCESS

ACTIVE COMPARATOR

This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique.

Device: Pacemaker implantDevice: Defibrillator implantProcedure: AXILLARY VEIN ACCESS

CEPHALIC VEIN ACCESS

ACTIVE COMPARATOR

This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique.

Device: Pacemaker implantDevice: Defibrillator implantProcedure: CEPHALIC VEIN ACCESS

Interventions

Pacemaker implantDEVICE

Implantation of endovenous cardiac stimulation device.

AXILLARY VEIN ACCESSCEPHALIC VEIN ACCESS
Defibrillator implantDEVICE

Implantation of endovenous cardiac defibrillation device.

AXILLARY VEIN ACCESSCEPHALIC VEIN ACCESS
AXILLARY VEIN ACCESSPROCEDURE

Fluoroscopy-guided axillary puncture to get vein access

AXILLARY VEIN ACCESS
CEPHALIC VEIN ACCESSPROCEDURE

Optimized cephalic vein cutdown to get vein access

CEPHALIC VEIN ACCESS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a endovenous pacemaker or defibrillator indication.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Related Publications (3)

  • 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.

    PMID: 11341082BACKGROUND

  • 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.

    PMID: 28064251BACKGROUND

  • 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.

    PMID: 31310038DERIVED

MeSH Terms

Interventions

Defibrillators

Intervention Hierarchy (Ancestors)

ElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Javier Jiménez Díaz, Dr.

    Arrhythmia Unit Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 1, 2019

Study Start

October 1, 2017

Primary Completion

February 20, 2019

Study Completion

October 1, 2022

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication. No end date.
Access Criteria
Anyone who wishes to access the data.

Locations

ES(1)