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

ConditionCardiac Conduction Disturbance
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cardiac pacemaker with atrial lead indication

Disqualifiers

patients < 18 years old

pregnancy of breast feeding

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with cardiac pace-maker indication and atrial lead indication1 intervention

Trial outcomes

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.

Time frame
10 minutes

Secondary outcomes

1

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

Time frame
3 months
2

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

Time frame
12 months
3

AF burden after 12 months follow-up

Time frame
12 months follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Caen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: