Bachstim Registry: a Feasability Study of Bachmann's Area Pacing

NCT07467031 | Not Yet Recruiting FDA Device

• 1 other identifier: Bachstim Registry
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

During pacemaker implantation, the atrial lead is commonly positioned in the right atrium. However, this pacing location can be problematic because it may disrupt physiological atrial activation, leading to atrial dyssynchrony. Such dyssynchrony has been associated with an increased risk of atrial fibrillation and its related complications. To mitigate atrial dyssynchrony, pacing of the Bachmann's bundle region has emerged as an alternative strategy. Bachmann's bundle is the principal interatrial conduction pathway, and pacing at this site may help preserve physiological atrial activation. Several studies have suggested that pacing in this region can significantly reduce the incidence of new-onset atrial fibrillation and heart failure in selected populations. To date, however, robust data from large cohorts regarding the feasibility of Bachmann's bundle area pacing and the factors associated with successful implantation remain limited. To address this gap, we established the Bachstim cohort study, aimed at determining the success rate of Bachmann's bundle area pacing and identifying the clinical and procedural factors associated with its feasibility.

Conditions

Cardiac Conduction Disturbance

Outcome Measures

Primary Outcomes (1)

• Success of Bachmann's area pacing

  Successful Bachmann's bundle area pacing is defined by a reduction of the paced P-wave duration by at least 30 ms when the spontaneous P-wave duration exceeds 120 ms, or by a reduction of the paced P-wave duration by at least 10 ms when the spontaneous P-wave duration is ≤120 ms.

  10 minutes

Secondary Outcomes (3)

• Success of Bachmann's area pacing after 3 months follow-up

  3 months

• Success of Bachmann's area pacing after12 months follow-up

  12 months

• AF burden after 12 months follow-up

  12 months follow-up

Study Arms (1)

Patients with cardiac pace-maker indication and atrial lead indication

Device: Bachmann's area pacing

Interventions

Bachmann's area pacing DEVICE

In this study, the atrial lead will be targeted to the Bachmann's bundle area, rather than the conventional right atrial appendage pacing site.

Patients with cardiac pace-maker indication and atrial lead indication

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

The study population will include all patients with an indication for cardiac pacemaker implantation requiring an atrial lead, in whom Bachmann's bundle area pacing is planned. Patients with age inferior to 18 years old will be excluded.

You may qualify if:

• Cardiac pacemaker with atrial lead indication

You may not qualify if:

• patients \< 18 years old
• pregnancy of breast feeding

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

Related Publications (3)

• Infeld M, Habel N, Wahlberg K, Meagher S, Meyer M, Lustgarten D. Bachmann bundle potential during atrial lead placement: A case series. Heart Rhythm. 2022 Mar;19(3):490-494. doi: 10.1016/j.hrthm.2021.11.015. Epub 2021 Nov 12. No abstract available.

  PMID: 34775070 BACKGROUND

• Lee WC, Jeng LB, Lin PJ, Chu Y, Hung CM, Yu MC, Chang CC. Nitric oxide donor improved the impaired endothelial-dependent relaxation of canine hepatic artery after preservation with UW solution. Transplant Proc. 2000 Nov;32(7):2306-7. doi: 10.1016/s0041-1345(00)01675-4. No abstract available.

  PMID: 11120176 BACKGROUND

• 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.

  PMID: 11513442 BACKGROUND

Central Study Contacts

Jonaz FONT, MD, MSc

CONTACT

00332315118; font-j@chu-caen.fr

Study Design

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

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)