Cardiac Conduction DisturbanceNCT07467031
Bachstim Registry: a Feasability Study of Bachmann's Area Pacing
An observational study of Cardiac Conduction Disturbance, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Conduction Disturbance
- What is being tested?
- Bachmann's area pacing
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Cardiac pacemaker with atrial lead indication
Who cannot join
- patients < 18 years old
- pregnancy of breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Caen University Hospital
Caen
jonaz FONT, MD, MSc, 00332315118, jnzfnt@gmail.com
About this study
Official title: 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.
- Conditions
- Cardiac Conduction Disturbance
- Being tested
- Bachmann's area pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bachmann's area pacingDevice
In this study, the atrial lead will be targeted to the Bachmann's bundle area, rather than the conventional right atrial appendage pacing site.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiac pace-maker indication and atrial lead indication | Not described Receives: Device: Bachmann's area pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (3)
Success of Bachmann's area pacing after 3 months follow-up
Measured: 3 months
Success of Bachmann's area pacing after12 months follow-up
Measured: 12 months
AF burden after 12 months follow-up
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Conduction DisturbanceStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim ALEXANDRE, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467031
- Sponsor's protocol ID
- Bachstim Registry
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 34775070Lee 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.
PubMed 11120176Bailin 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BACHSTIM REGISTRY: a Feasability Prospective Study of Bachmann's Area Pacing
- ClinicalTrials.gov ID
- NCT07467031
- Acronym / sponsor ID
- Bachstim Registry
- Conditions
- Cardiac Conduction Disturbance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiac pace-maker indication and atrial lead indication | – | Device: Bachmann's area pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Cardiac pacemaker with atrial lead indication
Key exclusion criteria (2 listed)
- patients < 18 years old
- pregnancy of breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bachmann's area pacingIn this study, the atrial lead will be targeted to the Bachmann's bundle area, rather than the conventional right atrial appendage pacing site. | Device | Patients with cardiac pace-maker indication and atrial lead indication |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 34775070Infeld 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.
- Background: PubMed 11120176Lee 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.
- Background: PubMed 11513442Bailin 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Conduction Disturbance
Recruiting
4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality
4-electrode Tablet-based Electrocardiogram (ECG) System, Electrical Activity of the Heart
Recruiting
Remote Cardiovascular Monitoring in Post-TAVI Patients
Aortic Valve Stenosis, Cardiac Conduction Disturbance
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
Recruiting
Reversibility of Cardiac Conduction Disturbances Following TAVI
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Conduction Disturbance, run by University Hospital, Caen at 1 site in France.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Mar 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 France. 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 Jonaz FONT, MD, MSc (00332315118, font-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Bachmann's area pacing (time frame: 10 minutes). 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 NCT07467031, which also lists 3 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 12 Mar 2026.