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

February 28, 2019 updated by: Castilla-La Mancha Health Service

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario de Ciudad Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AXILLARY VEIN ACCESS
This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique.
Device: Pacemaker implant
Implantation of endovenous cardiac stimulation device.
Device: Defibrillator implant
Implantation of endovenous cardiac defibrillation device.
Procedure: AXILLARY VEIN ACCESS
Fluoroscopy-guided axillary puncture to get vein access
ACTIVE_COMPARATOR: CEPHALIC VEIN ACCESS
This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique.
Device: Pacemaker implant
Implantation of endovenous cardiac stimulation device.
Device: Defibrillator implant
Implantation of endovenous cardiac defibrillation device.
Procedure: CEPHALIC VEIN ACCESS
Optimized cephalic vein cutdown to get vein access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Success
Time Frame: 30 days
Success of the implant through the assigned access vein
30 days
Implant Complications
Time Frame: 30 days
All implant related complications
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead Complications
Time Frame: From date of implant until the date of first documented, assessed up to 48 months
Lead fracture or dysfunction
From date of implant until the date of first documented, assessed up to 48 months
Upper limb thrombosis
Time Frame: From date of implant until the date of first documented, assessed up to 48 months
Thrombosis of the ipsilateral upper limb
From date of implant until the date of first documented, assessed up to 48 months
Pneumothorax
Time Frame: 30 days
Implant related pneumothorax
30 days
Bleeding
Time Frame: 30 days
Implant related bleeding
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to access.
Time Frame: From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes.
Time until reaching venous access.
From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes.
Time of implant.
Time Frame: From the skin incision to the skin suture, assessed up to 180 minutes.
Intervention time.
From the skin incision to the skin suture, assessed up to 180 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Investigators

  • Principal Investigator: Javier Jiménez Díaz, Dr., Arrhythmia Unit Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

February 20, 2019

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (ACTUAL)

March 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A-276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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