Leadless PacemakerNCT06702865
Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry
An observational study of Leadless Pacemaker and Left Atrial Appendage Occlusion, 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 selected patients. Implantation is performed with a large caliber delivery catheter. Care must be taken in introducing the delivery catheter into the patient's venous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leadless Pacemaker, Left Atrial Appendage Occlusion
- How many people
- 47 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2024to Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient in Prince of Wales Hospital who is deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient
Who may be able to join
- Age > 18-year-old
- Patients satisfying guideline Class I or Class II indication for pacemaker 6,7
- Patients with atrial fibrillation
- Patient deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient
Who cannot join
- Pregnancy
- Expected life expectancy <1 year
- Patients with known mitral stenosis
- LVEF <30%
- Severe mitral regurgitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong
Tammy Yeung, 852 35051750, tammyooyeung@cuhk.edu.hk
About this study
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in selected patients. Implantation is performed with a large caliber delivery catheter. Care must be taken in introducing the delivery catheter into the patient's venous system. Implantation in patients with small body habitus demands extra caution to avoid vascular injury and cardiac perforation. Negotiating the large caliber delivery catheter into the desired implant position may also be more difficult in small right ventricles. In a previous report of Micra leadless pacemakers, it was found that low BMI was associated with poor efficacy and safety.
The Aveir leadless pacemaker is a new leadless pacemaker that has obtained FDA approval and is commercially available in Hong Kong. It features a screw-in fixation mechanism, in contrast to the passive fixation of Micra. Most of its efficacy and safety data comes from a Western population. It would be important to study its efficacy and safety in an Asian population, who tend to have smaller body builds, hence more prone to complications.
Read more
In recent papers regarding the Micra leadless pacemaker, it was found that tricuspid regurgitation (TR) could be a result, especially if the implant was too close to the tricuspid valve. Given the almost 50% longer device dimension of the Aveir VR compared with the Micra leadless pacemaker (38mm vs 26mm), it is expected that the device mechanical interaction with tricuspid valve dysfunction can be more common. In the smaller hearts of an Asian population, it would be important to study the TR progression after device implantation.
About half of the patients implanted with leadless pacemakers were having concomitant atrial fibrillation and thus were at risk for thromboembolic events. Left atrial appendage occlusion was an effective procedure for stroke prevention in patients with atrial fibrillation. Because one patient often has indication for both LAAO and leadless pacemaker, combining them into the same procedure is appealing. The combined procedure can be performed with one single access. The imaging used to guide LAAO implantation can also be used to guide leadless pacemaker implantation to improve the procedure safety.
This study is a prospective observational study. Patients indicated for combined leadless pacemaker and left atrial appendage occlusion will be enrolled. Patients would fulfill guideline Class I and Class II indication for leadless pacemaker. The decision for left atrial appendage occlusion will be a shared decision-making process between the physician and patient. The consideration is usually based on patient's bleeding risk, tolerability for oral anticoagulation and patient preference.
Read the detailed description
Baseline demographics will be collected, including body weight, body height, age, sex, comorbidities, indication of pacing and indication of left atrial appendage occlusion, etc.
Implantation of pacemaker will be performed with usual implantation techniques. During the implantation, procedural details will be collected. Any complications related to the implantation will be collected as well.
The implantation of LAAO will be performed with usual implantation techniques. Image guidance will be employed, such as transesophageal echocardiogram or intracardiac echocardiogram.
Patients will be followed up per routine clinical practice. During the clinical follow up, device measurements will be recorded. If any imaging is performed during follow up, the result will be recorded.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LP and LAAO | Patients indicated for combined leadless pacemaker and left atrial appendage occlusion will have combined procedure. Procedure will be performed with usual implantation techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success rate
Evaluate implant success rate for both leadless pacemaker and left atrial appendage occlusion
Measured: From implant to the date of study end, up to 12 months
Implant complications
Evaluate Implant complications
Measured: From implant to the date of study end, up to 12 months
Secondary outcomes (5)
Pacing parameters
Evaluate pacing parameters in follow up visits
Measured: From implant to the date of study end, up to 12 months
Leadless pacemaker implantation locations
Evaluate implantation location of leadless pacemaker
Measured: From implant to the date of study end, up to 12 months
Imaging
Follow up imaging results (CT or TEE) for leadless pacemaker and left atrial appendage occlusion
Measured: From implant to the date of study end, up to 12 months
Rate of increase in tricuspid regurgitation severity
Evaluate rate of increase in tricuspid regurgitation severity by >=1 grade after leadless pacemaker implantation
Measured: From implant to the date of study end, up to 12 months
Procedure time
Evaluate the procedure time of combined procedure
Measured: On procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
- Target duration
- 1 Year
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
- NCT06702865
- Sponsor's protocol ID
- LP LAAO registry
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry
- ClinicalTrials.gov ID
- NCT06702865
- Acronym / sponsor ID
- LP LAAO registry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 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 selected patients. Implantation is performed with a large caliber delivery catheter. Care must be taken in introducing the delivery catheter into the patient's venous system. Implantation in patients with small body habitus demands extra caution to avoid vascular injury and cardiac perforation. Negotiating the large caliber delivery catheter into the desired implant position may also be more difficult in small right ventricles. In a previous report of Micra leadless pacemakers, it was found that low BMI was associated with poor efficacy and safety.
The Aveir leadless pacemaker is a new leadless pacemaker that has obtained FDA approval and is commercially available in Hong Kong. It features a screw-in fixation mechanism, in contrast to the passive fixation of Micra. Most of its efficacy and safety data comes from a Western population. It would be important to study its efficacy and safety in an Asian population, who tend to have smaller body builds, hence more prone to complications.
In recent papers regarding the Micra leadless pacemaker, it was found that tricuspid regurgitation (TR) could be a result, especially if the implant was too close to the tricuspid valve. Given the almost 50% longer device dimension of the Aveir VR compared with the Micra leadless pacemaker (38mm vs 26mm), it is expected that the device mechanical interaction with tricuspid valve dysfunction can be more common. In the smaller hearts of an Asian population, it would be important to study the TR progression after device implantation.
About half of the patients implanted with leadless pacemakers were having concomitant atrial fibrillation and thus were at risk for thromboembolic events. Left atrial appendage occlusion was an effective procedure for stroke prevention in patients with atrial fibrillation. Because one patient often has indication for both LAAO and leadless pacemaker, combining them into the same procedure is appealing. The combined procedure can be performed with one single access. The imaging used to guide LAAO implantation can also be used to guide leadless pacemaker implantation to improve the procedure safety.
This study is a prospective observational study. Patients indicated for combined leadless pacemaker and left atrial appendage occlusion will be enrolled. Patients would fulfill guideline Class I and Class II indication for leadless pacemaker. The decision for left atrial appendage occlusion will be a shared decision-making process between the physician and patient. The consideration is usually based on patient's bleeding risk, tolerability for oral anticoagulation and patient preference.
Detailed description
Baseline demographics will be collected, including body weight, body height, age, sex, comorbidities, indication of pacing and indication of left atrial appendage occlusion, etc.
Implantation of pacemaker will be performed with usual implantation techniques. During the implantation, procedural details will be collected. Any complications related to the implantation will be collected as well.
The implantation of LAAO will be performed with usual implantation techniques. Image guidance will be employed, such as transesophageal echocardiogram or intracardiac echocardiogram.
Patients will be followed up per routine clinical practice. During the clinical follow up, device measurements will be recorded. If any imaging is performed during follow up, the result will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LP and LAAO | – | –Patients indicated for combined leadless pacemaker and left atrial appendage occlusion will have combined procedure. Procedure will be performed with usual implantation techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in Prince of Wales Hospital who is deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient
Key inclusion criteria (4 listed)
- Age > 18-year-old
- Patients satisfying guideline Class I or Class II indication for pacemaker 6,7
- Patients with atrial fibrillation
- Patient deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient
Key exclusion criteria (5 listed)
- Pregnancy
- Expected life expectancy <1 year
- Patients with known mitral stenosis
- LVEF <30%
- Severe mitral regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant success rate
Time frame: From implant to the date of study end, up to 12 months
Evaluate implant success rate for both leadless pacemaker and left atrial appendage occlusion
Implant complications
Time frame: From implant to the date of study end, up to 12 months
Evaluate Implant complications
5 secondary outcomes
Pacing parameters
Time frame: From implant to the date of study end, up to 12 months
Leadless pacemaker implantation locations
Time frame: From implant to the date of study end, up to 12 months
Imaging
Time frame: From implant to the date of study end, up to 12 months
Rate of increase in tricuspid regurgitation severity
Time frame: From implant to the date of study end, up to 12 months
Procedure time
Time frame: On procedure date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
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 Leadless Pacemaker and Left Atrial Appendage Occlusion, 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
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?
Implant success rate (time frame: From implant to the date of study end, up to 12 months). 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?
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 25 Nov 2024.