Bachstim Registry: a Feasability Study of Bachmann's Area Pacing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bachmann's area pacing.
- Who it may be relevant to
- Registry conditions: Cardiac Conduction Disturbance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BACHSTIM REGISTRY: a Feasability Prospective Study of Bachmann's Area Pacing
Overview
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.
Interventions
- 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.
Primary outcome measures
- Success of Bachmann's area pacing [Time frame: 10 minutes]
Secondary outcome measures (3)
- Success of Bachmann's area pacing after 3 months follow-up [Time frame: 3 months]
- Success of Bachmann's area pacing after12 months follow-up [Time frame: 12 months]
- AF burden after 12 months follow-up [Time frame: 12 months follow-up]
Eligibility criteria
Inclusion criteria
- Cardiac pacemaker with atrial lead indication
Exclusion criteria
- patients < 18 years old
- pregnancy of breast feeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Caen University Hospital — Caen
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07467031 · Bachstim Registry