Mechanical Complication of Cardiac PacemakerNCT02358551
Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
A study testing Placement of electrode lead through axillary vein puncture and Placement of electrode lead through subclavian vein puncture in people with Mechanical Complication of Cardiac Pacemaker, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Complication of Cardiac Pacemaker
- What is being tested?
- Placement of electrode lead through axillary vein puncture and Placement of electrode lead through subclavian vein puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jan 2017
- 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 indication of pacemaker or ICD implantation
- Personally signed and dated informed consent document
Who cannot join
- Accompanied with malignant disease or other disease, which cause life expectancy < 1 year.
- Anatomical variation of axillary vein or subclavian vein, unable to puncture.
- Poor compliance for follow-up.
- Patients with any condition which, in the investigator's judgment, not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Chen Wang, MD, 86-10-84205566, zryyyb@126.com
About this study
The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this approach has been proposed for 20 years. The major concern is the learning curve for axillary vein puncture and its success rate. The investigators try to prove that the success rate of axillary vein puncture is non-inferior to subclavian vein puncture, hence to promote the clinical application of axillary vein puncture to reduce pacemaker implantation complications.
- Being tested
- Placement of electrode lead through axillary vein puncture, Placement of electrode lead through subclavian vein puncture
- Keywords
- Pacemaker, Axillary Vein, Subclavian vein, Clinical Study, Cardiovascular implantable electronic devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of electrode lead through axillary vein punctureDevice
Placement of electrode lead through subclavian vein punctureDevice
| Study group | Role | What they receive |
|---|---|---|
| Axillary vein | Other | Lead Placement Through the Axillary Vein Technique Receives: Device: Placement of electrode lead through axillary vein puncture |
| Subclaivan vein | Other | Lead Placement Through the Subclavian Vein Technique Receives: Device: Placement of electrode lead through subclavian vein puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of vein puncture
Measured: 1 Day
Secondary outcomes (2)
Mechanical complication of electrode lead (combined endpoints of hemothorax, pneumothorax, air embolism, inadvertent arterial puncture, hematoma, fracture of electrode lead, nerve injury and subclavian crush syndrome)
Measured: 6 months
Duration of pacemaker implantation
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Complication of Cardiac PacemakerStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianlun Li, China-Japan Friendship Hospital
- Investigators
- Xianlun Li, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358551
- Sponsor's protocol ID
- CJFH-2014-086
- Status last verified
- Feb 2015
- First submitted
- 25 Jan 2015
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu P, Zhou YF, Yang P, Gao YS, Zhao GR, Ren SY, Li XL. Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study. Chin Med J (Engl). 2016 Nov 20;129(22):2647-2651. doi: 10.4103/0366-6999.193462.
PubMed 27823994
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT02358551
- Acronym / sponsor ID
- CJFH-2014-086
- Keywords
- Pacemaker, Axillary Vein, Subclavian vein, Clinical Study, Cardiovascular implantable electronic devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 9 Feb 2015 (estimated)
- 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.
The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this approach has been proposed for 20 years. The major concern is the learning curve for axillary vein puncture and its success rate. The investigators try to prove that the success rate of axillary vein puncture is non-inferior to subclavian vein puncture, hence to promote the clinical application of axillary vein puncture to reduce pacemaker implantation complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary vein | Other | Device: Placement of electrode lead through axillary vein punctureLead Placement Through the Axillary Vein Technique |
| Subclaivan vein | Other | Device: Placement of electrode lead through subclavian vein punctureLead Placement Through the Subclavian Vein Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with indication of pacemaker or ICD implantation
- Personally signed and dated informed consent document
Key exclusion criteria (4 listed)
- Accompanied with malignant disease or other disease, which cause life expectancy < 1 year.
- Anatomical variation of axillary vein or subclavian vein, unable to puncture.
- Poor compliance for follow-up.
- Patients with any condition which, in the investigator's judgment, not suitable for enrollment.
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 |
|---|---|---|
| Placement of electrode lead through axillary vein puncture | Device | Axillary vein |
| Placement of electrode lead through subclavian vein puncture | Device | Subclaivan vein |
Primary outcome
Success rate of vein puncture
Time frame: 1 Day
2 secondary outcomes
Mechanical complication of electrode lead (combined endpoints of hemothorax, pneumothorax, air embolism, inadvertent arterial puncture, hematoma, fracture of electrode lead, nerve injury and subclavian crush syndrome)
Time frame: 6 months
Duration of pacemaker implantation
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Derived from this study: PubMed 27823994Liu P, Zhou YF, Yang P, Gao YS, Zhao GR, Ren SY, Li XL. Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study. Chin Med J (Engl). 2016 Nov 20;129(22):2647-2651. doi: 10.4103/0366-6999.193462.
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.
Xianlun Li, MD principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of electrode lead through axillary vein puncture and Placement of electrode lead through subclavian vein puncture in people with Mechanical Complication of Cardiac Pacemaker, run by China-Japan Friendship Hospital at 1 site in China.
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 2 inclusion and 4 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 9 Feb 2015. 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 China. 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?
Contact Xianlun Li, MD (86-10-84206151, leexianlun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of vein puncture (time frame: 1 Day). 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 NCT02358551, which also lists 1 linked publication.
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 9 Feb 2015.