Leadless PacemakerNCT06692218
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
A study testing Leadless pacemaker in people with Leadless Pacemaker, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leadless Pacemaker
- What is being tested?
- Leadless pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Aug 2024to 30 Sep 2025
- 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 who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015
- Patients with ability to provide informed consent
Who cannot join
- Patients who cannot provide informed consent
- Patient \< 18 years old
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Tammy Yeung, 35051750, tammyooyeung@cuhk.edu.hk
Tsz-Kin Mark Tam
About this study
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.
This is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).
- Conditions
- Leadless Pacemaker
- Being tested
- Leadless pacemaker
- Keywords
- Leadless pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless pacemakerDevice
Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast, ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed.
| Study group | Role | What they receive |
|---|---|---|
| CT | Other | All patients will have a non-contrast, ECG-gated CT heart to adjudicate implant position of leadless pacemaker. Receives: Device: Leadless pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of leadless pacemaker implantation
Determine the exact location of leadless pacemaker implantation
Measured: From date of enrollment to date of CT or echocardiogram, up to 1 year
Secondary outcomes (1)
Implant location prediction with electrical parameters
Correlate leadless pacemaker electrical parameters (including electrogram characteristics, pacing threshold and sensing) to leadless pacemaker implant position (septal, apex or free wall).
Measured: From date of enrollment to date of CT or echocardiogram, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start5 Aug 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leadless PacemakerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tam Tsz Kin, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692218
- Sponsor's protocol ID
- Leadless-CT study
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
- ClinicalTrials.gov ID
- NCT06692218
- Acronym / sponsor ID
- Leadless-CT study
- Conditions
- Leadless Pacemaker
- Keywords
- Leadless pacemaker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Nov 2024 (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.
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.
This is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT | Other | Device: Leadless pacemakerAll patients will have a non-contrast, ECG-gated CT heart to adjudicate implant position of leadless pacemaker. |
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 who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015
- Patients with ability to provide informed consent
Key exclusion criteria (3 listed)
- Patients who cannot provide informed consent
- Patient \< 18 years old
- Pregnant patients
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 pacemakerPatients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast, ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. | Device | CT |
Primary outcome
Location of leadless pacemaker implantation
Time frame: From date of enrollment to date of CT or echocardiogram, up to 1 year
Determine the exact location of leadless pacemaker implantation
1 secondary outcome
Implant location prediction with electrical parameters
Time frame: From date of enrollment to date of CT or echocardiogram, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leadless pacemaker in people with Leadless Pacemaker, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 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 18 Nov 2024. 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 Hong Kong. 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 Tsz Kin Mark Tam (852 35051750, marktam@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of leadless pacemaker implantation (time frame: From date of enrollment to date of CT or echocardiogram, up to 1 year). 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 18 Nov 2024.