PacemakersCEPHAXNCT03860090
Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
A study testing Pacemaker implant, Defibrillator implant and AXILLARY VEIN ACCESS in people with Pacemakers and Defibrillators, run by Castilla-La Mancha Health Service at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemakers, Defibrillators, Complication
- What is being tested?
- Pacemaker implant, Defibrillator implant and AXILLARY VEIN ACCESS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a endovenous pacemaker or defibrillator indication.
Who cannot join
- Pre-existing ipsilateral pacing electrode.
- Previous ipsilateral lymphadenectomy.
- Indication of cardiac resynchronization therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Pacemaker implant, Defibrillator implant, AXILLARY VEIN ACCESS, CEPHALIC VEIN ACCESS
- Keywords
- Cephalic Vein, Axillary Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantDevice
Implantation of endovenous cardiac stimulation device.
Defibrillator implantDevice
Implantation of endovenous cardiac defibrillation device.
AXILLARY VEIN ACCESSProcedure or surgery
Fluoroscopy-guided axillary puncture to get vein access
CEPHALIC VEIN ACCESSProcedure or surgery
Optimized cephalic vein cutdown to get vein access
| Study group | Role | What they receive |
|---|---|---|
| AXILLARY VEIN ACCESS | Active comparator | This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique. Receives: Device: Pacemaker implant; Device: Defibrillator implant; Procedure: AXILLARY VEIN ACCESS |
| CEPHALIC VEIN ACCESS | Active comparator | This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique. Receives: Device: Pacemaker implant; Device: Defibrillator implant; Procedure: CEPHALIC VEIN ACCESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Success
Success of the implant through the assigned access vein
Measured: 30 days
Implant Complications
All implant related complications
Measured: 30 days
Secondary outcomes (4)
Lead Complications
Lead fracture or dysfunction
Measured: From date of implant until the date of first documented, assessed up to 48 months
Upper limb thrombosis
Thrombosis of the ipsilateral upper limb
Measured: From date of implant until the date of first documented, assessed up to 48 months
Pneumothorax
Implant related pneumothorax
Measured: 30 days
Bleeding
Implant related bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Oct 2017
- Primary completion20 Feb 2019
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PacemakersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Jiménez Díaz, Dr., Principal investigator, Arrhythmia Unit Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860090
- Sponsor's protocol ID
- A-276
- Acronym
- CEPHAX
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 11341082Squara 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.
PubMed 28064251Jimenez-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.
PubMed 31310038
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access. The CEPHAX Study.
- ClinicalTrials.gov ID
- NCT03860090
- Acronym / sponsor ID
- CEPHAX / A-276
- Keywords
- Cephalic Vein, Axillary Vein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXILLARY VEIN ACCESS | Active comparator | Device: Pacemaker implant, Device: Defibrillator implant, Procedure: AXILLARY VEIN ACCESSThis group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique. |
| CEPHALIC VEIN ACCESS | Active comparator | Device: Pacemaker implant, Device: Defibrillator implant, Procedure: CEPHALIC VEIN ACCESSThis group of subjects will receive the implant of device via optimized cephalic vein cutdown technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a endovenous pacemaker or defibrillator indication.
Key exclusion criteria (3 listed)
- Pre-existing ipsilateral pacing electrode.
- Previous ipsilateral lymphadenectomy.
- Indication of cardiac resynchronization therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantImplantation of endovenous cardiac stimulation device. | Device | AXILLARY VEIN ACCESS, CEPHALIC VEIN ACCESS |
| Defibrillator implantImplantation of endovenous cardiac defibrillation device. | Device | AXILLARY VEIN ACCESS, CEPHALIC VEIN ACCESS |
| AXILLARY VEIN ACCESSFluoroscopy-guided axillary puncture to get vein access | Procedure or surgery | AXILLARY VEIN ACCESS |
| CEPHALIC VEIN ACCESSOptimized cephalic vein cutdown to get vein access | Procedure or surgery | CEPHALIC VEIN ACCESS |
Primary outcome
Implant Success
Time frame: 30 days
Success of the implant through the assigned access vein
Implant Complications
Time frame: 30 days
All implant related complications
4 secondary outcomes
Lead Complications
Time frame: 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
Pneumothorax
Time frame: 30 days
Bleeding
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Background: PubMed 11341082Calkins 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.
- Background: PubMed 28064251Squara 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.
- Derived from this study: PubMed 31310038Jimenez-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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Jiménez Díaz, Dr. principal investigator
Arrhythmia Unit Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implant, Defibrillator implant and AXILLARY VEIN ACCESS in people with Pacemakers and Defibrillators, run by Castilla-La Mancha Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Success (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860090, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.