Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Left Atrial Appendage Occlusion; Leadless Pacemaker

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 Type: Observational
• Enrollment (Estimated): 47

Contacts and Locations

• Study Contact: Name: Tsz Kin Mark Tam; Phone Number: 852 35051750; Email: marktam@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
    • Contact: Tammy Yeung; Phone Number: 852 35051750; Email: tammyooyeung@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Age > 18-year-old
2. Patients satisfying guideline Class I or Class II indication for pacemaker 6,7
3. Patients with atrial fibrillation
4. Patient deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient

Exclusion Criteria:

1. Pregnancy
2. Expected life expectancy <1 year
3. Patients with known mitral stenosis
4. LVEF <30%
5. Severe mitral regurgitation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant success rate	Evaluate implant success rate for both leadless pacemaker and left atrial appendage occlusion	From implant to the date of study end, up to 12 months
Implant complications	Evaluate Implant complications	From implant to the date of study end, up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pacing parameters	Evaluate pacing parameters in follow up visits	From implant to the date of study end, up to 12 months
Leadless pacemaker implantation locations	Evaluate implantation location of leadless pacemaker	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	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	From implant to the date of study end, up to 12 months
Procedure time	Evaluate the procedure time of combined procedure	On procedure date

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LP LAAO registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes