Complication of Surgical ProcedureNCT05761821
Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
An observational study of Complication of Surgical Procedure and Pacemaker Complication, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical Procedure, Pacemaker Complication, Pacemaker Syndrome
- What is being tested?
- Leadless pacemaker
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients received implantation of leadless pacemaker
Who may be able to join
- Patient received implantation of leadless pacemaker
- Patient agreed to join into this study and signed informed consent
Who cannot join
- Age < 18 years
- Ventricular septal defect
- History of mechanical tricuspid valve replacement
- History of inferior vena cava filter placement
- Pregnant or plan to be pregnant within 2 years
- Life expectancy < 1 year
- Patient was included in other studies that could introduce bias into this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yangxin Chen, PhD, +8602081332360, chenyx39@mail.sysu.edu.cn
Qi Guo, MD
About this study
Official title: Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.
Read the detailed description
In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.
- Being tested
- Leadless pacemaker
- Keywords
- leadless pacemaker, complication, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless pacemakerDevice
All enrolled patients were implanted with leadless pacemaker.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection
Measured: Day 0 (Time of implantation)-Day 7
Secondary outcomes (4)
Device-related complications
Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury
Measured: Day 0 (Time of implantation)-Day 7
Device-related complications
Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous
Measured: Day 0 (Time of implantation)-Year 2
Serious adverse events
including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection
Measured: Day 0 (Time of implantation)-Year 2
Re-intervention of devices
extraction, re-implantation, or implantation of traditional transvenous pacemaker
Measured: Day 0 (Time of implantation)-Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangxin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yangxin Chen, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761821
- Sponsor's protocol ID
- SYSKY-2023-056-01
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis
- ClinicalTrials.gov ID
- NCT05761821
- Acronym / sponsor ID
- SYSKY-2023-056-01
- Keywords
- leadless pacemaker, complication, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Mar 2023 (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.
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.
Detailed description
In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received implantation of leadless pacemaker
Key inclusion criteria (2 listed)
- Patient received implantation of leadless pacemaker
- Patient agreed to join into this study and signed informed consent
Key exclusion criteria (7 listed)
- Age < 18 years
- Ventricular septal defect
- History of mechanical tricuspid valve replacement
- History of inferior vena cava filter placement
- Pregnant or plan to be pregnant within 2 years
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 |
|---|---|---|
| Leadless pacemakerAll enrolled patients were implanted with leadless pacemaker. | Device | – |
Primary outcome
Serious adverse events
Time frame: Day 0 (Time of implantation)-Day 7
including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection
4 secondary outcomes
Device-related complications
Time frame: Day 0 (Time of implantation)-Day 7
Device-related complications
Time frame: Day 0 (Time of implantation)-Year 2
Serious adverse events
Time frame: Day 0 (Time of implantation)-Year 2
Re-intervention of devices
Time frame: Day 0 (Time of implantation)-Year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Yangxin Chen, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Surgical Procedure and Pacemaker Complication, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 7 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 Mar 2023. 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 Yangxin Chen, PhD (+8602081332360, chenyx39@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (time frame: Day 0 (Time of implantation)-Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.