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Sick Sinus SyndromeBRAVENCT07360067

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

An observational study of Sick Sinus Syndrome, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Sick Sinus Syndrome
What is being tested?
Right Atrial Appendage Pacing and Bachmann Bundle Pacing
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteSouth Korea
Study dates
9 Dec 2025to 31 Dec 2028
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juwon Kim, MD contact

82+ 10-2079-8154

abcd186a@naver.com

Ju Hee Lee, Bachelor contact

82+ 10-7180-3357

phacyde12@gmail.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, Seoul, 06351

    Juwon Kim, MD, 82+ 2-3410-3419, abcd186a@naver.com

    Recruiting

Other trials in South Korea

About this study

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.

Read the detailed description

Previous studies have reported that conventional Right Atrial Appendage pacing is associated with delayed atrial activation time. A higher burden of atrial pacing at this site has been linked to an increased incidence of atrial fibrillation and atrial tachycardia. Furthermore, structural and functional deterioration of the atria-specifically Left Atrial dilation and reduced left atrial strain-has been observed in patients with a high percentage of Right Atrial Appendage pacing. These changes are known to accelerate the progression of atrial cardiomyopathy, potentially leading to adverse long-term clinical outcomes.

To address these limitations, Bachmann Bundle Pacing has emerged as a promising alternative pacing site. The Bachmann bundle is a major atrial myoarchitecture connecting the right and left atria. Pacing at this site is expected to facilitate interatrial conduction, thereby restoring interatrial synchrony and mitigating interatrial block. Prior research indicates that pacing at the Bachmann bundle is associated with a reduced incidence of atrial fibrillation and atrial tachycardia, suggesting distinct benefits regarding atrial electrophysiological outcomes. However, existing studies have primarily focused on electrophysiological parameters, such as arrhythmia incidence. Consequently, the impact of Bachmann Bundle Pacing on atrial structural and functional remodeling remains to be clearly elucidated.

Therefore, this study is designed as a single-center cohort study enrolling a total of 200 subjects (100 prospective and 100 retrospective). The investigators will analyze echocardiographic parameters over a 12-month period following pacemaker implantation. By comprehensively analyzing imaging parameters (left atrial/right atrial strain and volume changes assessed via echocardiography) and clinical outcomes (atrial arrhythmias, heart failure hospitalization, and mortality), this study aims to investigate the differential effects of Bachmann Bundle Pacing versus Right Atrial Appendage pacing on the development and progression of atrial cardiomyopathy.

Being tested
Right Atrial Appendage Pacing, Bachmann Bundle Pacing
Keywords
bachmann bundle pacing
Medical subject headings
Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Right Atrial Appendage PacingProcedure or surgery

    Atrial lead positioned in the right atrial appendage

  • Bachmann Bundle PacingProcedure or surgery

    Atrial lead positioned in the bachmann bundle branch

Study groups in NCT07360067
Study groupRoleWhat they receive
Right Atrial Appendage PacingRight Atrial Appendage Pacing
Receives: Procedure: Right Atrial Appendage Pacing
Bachmann Bundle PacingBachmann Bundle Pacing
Receives: Procedure: Bachmann Bundle Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Structural echocardiographic parameters of the left atrium

    LA Volume Index measured as mL/m^2

    Measured: 6 and 12 months after pacemaker implantation

  2. Functional echocardiographic parameters of the left atrium

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

    Measured: 6 and 12 months after pacemaker implantation

Secondary outcomes (21)

  1. Structural echocardiographic parameters of the left ventricle

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

    Measured: 6 and 12 months after pacemaker implantation

  2. Functional echocardiographic parameters of the left ventricle

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

    Measured: 6 and 12 months after pacemaker implantation

  3. Mitral and tricuspid regurgitation volume

    as mL per beat

    Measured: 6 and 12 months after pacemaker implantation

  4. Structural echocardiographic parameters of the right atrium

    RA Volume Index (mL/m^2)

    Measured: 6 and 12 months after pacemaker implantation

  5. Functional echocardiographic parameters of the right atrium

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

    Measured: 6 and 12 months after pacemaker implantation

  6. ECG parameters

    PR interval (ms), QRS duration (ms), P wave duration (ms), QTC (ms)

    Measured: 6 and 12 months after pacemaker implantation

  7. Average heart rate

    bpm

    Measured: 6 and 12 months after pacemaker implantation

  8. Heart rate distribution

    percentage (%)

    Measured: 6 and 12 months after pacemaker implantation

  9. Pacing burden

    percentage (%)

    Measured: 6 and 12 months after pacemaker implantation

  10. Atrial fibrillation burden

    percentage (%)

    Measured: 6 and 12 months after pacemaker implantation

  11. atrial fibrillation occurrence

    count

    Measured: 6 and 12 months after pacemaker implantation

  12. NTproBNP

    pg/ml

    Measured: 6 and 12 months after pacemaker implantation

  13. Procedure-related complications

    count

    Measured: 6 and 12 months after pacemaker implantation

  14. Pacemaker/Implantable cardioverter defibrillator parameters

    Threshold (V)

    Measured: 6 and 12 months after pacemaker implantation

  15. Pacemaker/Implantable cardioverter defibrillator parameters

    longevity (year)

    Measured: 6 and 12 months after pacemaker implantation

  16. Cardiac mortality

    count

    Measured: 6 and 12 months after pacemaker implantation

  17. All-cause mortality

    count

    Measured: 6 and 12 months after pacemaker implantation

  18. Patient's functional status

    NYHA class I~IV

    Measured: 6 and 12 months after pacemaker implantation

  19. hospitalization due to heart failure

    count

    Measured: 6 and 12 months post-procedure

  20. re-admission due to any cause

    count

    Measured: 6 and 12 months post-procedure

  21. Cerebrovascular event

    count

    Measured: 6 and 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start9 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360067
Sponsor's protocol ID
SMC2025-10-106
Other IDs
KCT0011382
Acronym
BRAVE
Status last verified
Jan 2026
First submitted
14 Jan 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bailin SJ, Adler S, Giudici M. Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial. J Cardiovasc Electrophysiol. 2001 Aug;12(8):912-7. doi: 10.1046/j.1540-8167.2001.00912.x.

    PubMed 11513442

  • Infeld M, Nicoli CD, Meagher S, Tompkins BJ, Wayne S, Irvine B, Betageri O, Habel N, Till S, Lobel J, Meyer M, Lustgarten DL. Clinical impact of Bachmann's bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes. Europace. 2022 Oct 13;24(9):1460-1468. doi: 10.1093/europace/euac029.

    PubMed 35304608

  • Lustgarten DL, Habel N, Sanchez-Quintana D, Winget J, Correa de Sa D, Lobel R, Thompson N, Infeld M, Meyer M. Bachmann bundle pacing. Heart Rhythm. 2024 Sep;21(9):1711-1717. doi: 10.1016/j.hrthm.2024.03.1786. Epub 2024 Mar 27. No abstract available.

    PubMed 38552731

  • Martens P, Deferm S, Bertrand PB, Verbrugge FH, Ramaekers J, Verhaert D, Dupont M, Vandervoort PM, Mullens W. The Detrimental Effect of RA Pacing on LA Function and Clinical Outcome in Cardiac Resynchronization Therapy. JACC Cardiovasc Imaging. 2020 Apr;13(4):895-906. doi: 10.1016/j.jcmg.2019.04.022. Epub 2019 Jul 17.

    PubMed 31326478

  • Roithinger FX, Abou-Harb M, Pachinger O, Hintringer F. The effect of the atrial pacing site on the total atrial activation time. Pacing Clin Electrophysiol. 2001 Mar;24(3):316-22. doi: 10.1046/j.1460-9592.2001.00316.x.

    PubMed 11310300

  • De Sisti A, Leclercq JF, Stiubei M, Fiorello P, Halimi F, Attuel P. P wave duration and morphology predict atrial fibrillation recurrence in patients with sinus node dysfunction and atrial-based pacemaker. Pacing Clin Electrophysiol. 2002 Nov;25(11):1546-54. doi: 10.1046/j.1460-9592.2002.01546.x.

    PubMed 12494610

  • Elkayam LU, Koehler JL, Sheldon TJ, Glotzer TV, Rosenthal LS, Lamas GA. The influence of atrial and ventricular pacing on the incidence of atrial fibrillation: a meta-analysis. Pacing Clin Electrophysiol. 2011 Dec;34(12):1593-9. doi: 10.1111/j.1540-8159.2011.03192.x. Epub 2011 Aug 7.

    PubMed 21819434

  • Bradshaw PJ, Stobie P, Knuiman MW, Briffa TG, Hobbs MS. Trends in the incidence and prevalence of cardiac pacemaker insertions in an ageing population. Open Heart. 2014 Dec 10;1(1):e000177. doi: 10.1136/openhrt-2014-000177. eCollection 2014.

    PubMed 25512875

  • Honarbakhsh S, Hunter L, Chow A, Hunter RJ. Bradyarrhythmias and pacemakers. BMJ. 2018 Mar 15;360:k642. doi: 10.1136/bmj.k642. No abstract available.

    PubMed 29545242

  • Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2019 Aug 20;140(8):e382-e482. doi: 10.1161/CIR.0000000000000628. Epub 2018 Nov 6. No abstract available.

    PubMed 30586772

Questions about this trial

What is this clinical trial studying?

An observational study of Sick Sinus Syndrome, run by Samsung Medical Center at 1 site in South Korea.

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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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 South Korea. 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 Juwon Kim, MD (82+ 10-2079-8154, abcd186a@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Structural echocardiographic parameters of the left atrium (time frame: 6 and 12 months after pacemaker implantation). 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?

On the ClinicalTrials.gov record for NCT07360067, which also lists 10 linked publications.

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 28 Jul 2026.

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