Prospective Cohort Study of Bachmann Bundle Versus Right Atrial Appendage Pacing: Impact on Atrial Cardiomyopathy Evaluated by Echocardiographic Parameters and Clinical Outcome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

The goal of this observational study is to evaluate the impact of different atrial pacing sites-Bachmann's bundle pacing versus right atrial appendage pacing-on the development and progression of atrial cardiomyopathy in patients diagnosed with sick sinus syndrome who are undergoing permanent pacemaker implantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 19 years or older

Patients diagnosed with sick sinus syndrome who are scheduled for de novo implantation of a permanent pacemaker or permanent implantable cardioverter-defibrillator

Patients or their legal representatives who voluntarily consent to the access of medical records and study data throughout the entire research period

Disqualifiers

Patients with persistent or permanent AF

Patients with a life expectancy of less than one year due to other comorbidities

Pregnant or breastfeeding women

Patients who refuse active treatment

Trial population

Patients who presented to Samsung Medical Center, were diagnosed with Sick Sinus Syndrome, and underwent de novo permanent pacemaker or implantable cardioverter-defibrillator implantation based on clinical indications.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Right Atrial Appendage Pacing

    Procedure/Surgery

    Atrial lead positioned in the right atrial appendage

  • Bachmann Bundle Pacing

    Procedure/Surgery

    Atrial lead positioned in the bachmann bundle branch

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Right Atrial Appendage Pacing1 intervention
Group B: Bachmann Bundle Pacing1 intervention

Trial outcomes

Primary outcomes

1

Structural echocardiographic parameters of the left atrium

LA Volume Index measured as mL/m\^2

Time frame
6 and 12 months after pacemaker implantation
2

Functional echocardiographic parameters of the left atrium

Reservoir Strain (%), Conduit Strain (%), Contraction Strain (%)

Time frame
6 and 12 months after pacemaker implantation

Secondary outcomes

1

Structural echocardiographic parameters of the left ventricle

LV End-Diastolic Diameter(mm), LV End-Systolic Diameter(mm)

Time frame
6 and 12 months after pacemaker implantation
2

Functional echocardiographic parameters of the left ventricle

LV Ejection Fraction (%), Global Longitudinal Strain (%)

Time frame
6 and 12 months after pacemaker implantation
3

Mitral and tricuspid regurgitation volume

as mL per beat

Time frame
6 and 12 months after pacemaker implantation
4

Structural echocardiographic parameters of the right atrium

RA Volume Index (mL/m\^2)

Time frame
6 and 12 months after pacemaker implantation

Other outcomes

Sponsors and contacts

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