Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry

NCT06702865 | Not Yet Recruiting

• 1 other identifier: LP LAAO registry
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Leadless Pacemaker; Left Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Pacing parameters

  From implant to the date of study end, up to 12 months

• Leadless pacemaker implantation locations

  From implant to the date of study end, up to 12 months

• Imaging

  From implant to the date of study end, up to 12 months

• Rate of increase in tricuspid regurgitation severity

  From implant to the date of study end, up to 12 months

• Procedure time

  On procedure date

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Expected life expectancy \<1 year
• Patients with known mitral stenosis
• LVEF \<30%
• Severe mitral regurgitation

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Central Study Contacts

Tsz Kin Mark Tam

CONTACT

852 35051750; marktam@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 25, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-10

Locations

HK (1)