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

March 9, 2026 updated by: Joachim ALEXANDRE, University Hospital, Caen

BACHSTIM REGISTRY: a Feasability Prospective Study of Bachmann's Area Pacing

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
        • Caen University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Cardiac pacemaker with atrial lead indication

Exclusion Criteria:

  • patients < 18 years old
  • pregnancy of breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cardiac pace-maker indication and atrial lead indication
Device: Bachmann's area pacing
In this study, the atrial lead will be targeted to the Bachmann's bundle area, rather than the conventional right atrial appendage pacing site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of Bachmann's area pacing
Time Frame: 10 minutes
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 Outcome Measures

Outcome Measure
Time Frame
Success of Bachmann's area pacing after 3 months follow-up
Time Frame: 3 months
3 months
Success of Bachmann's area pacing after12 months follow-up
Time Frame: 12 months
12 months
AF burden after 12 months follow-up
Time Frame: 12 months follow-up
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Bachstim Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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