Atrial FibrillationNCT05153291
Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits
A study testing Bachmann's bundle lead placement and Right atrial appendage lead placement in people with Atrial Fibrillation, run by University of Vermont at 1 site in United States.
Trial summary
Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Bachmann's bundle lead placement and Right atrial appendage lead placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Subject is >18 years old
- Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
- Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)
- Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires
Who cannot join
- Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
- Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
- Subject has resting spontaneous sinus rate >85 beats-per-minute
- Subject has left ventricular ejection fraction <45%
- Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
- Subject is currently enrolled in a potentially confounding trial
- Subject is pregnant
- Subject's anticipated life expectancy is less than 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Electrically Guided Bachmann's Bundle Pacing Pilot Study: A Novel Lead Placement Strategy With Potential Antiarrhythmic Benefits
Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Bachmann's bundle lead placement, Right atrial appendage lead placement
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bachmann's bundle lead placementProcedure or surgery
Atrial lead placement at Bachmann's bundle area
Right atrial appendage lead placementProcedure or surgery
Atrial lead placement in the right atrial appendage
| Study group | Role | What they receive |
|---|---|---|
| Bachmann's bundle area pacing | Experimental | Lead placement in Bachmann's bundle area Receives: Procedure: Bachmann's bundle lead placement |
| Right atrial appendage pacing | Active comparator | Lead placement in the right atrial appendage Receives: Procedure: Right atrial appendage lead placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial arrhythmia burden from pacemaker counters
Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.
Measured: Over 15 month follow up
Secondary outcomes (14)
Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups
Measured: At implant
Atrial lead procedure time
Measured: At implant
Atrial lead fluoroscopy time
Measured: At implant
Atrial lead complications
Measured: Over 15 month follow up
Atrial lead capture threshold (Volts)
Measured: Over 15 month follow up
Atrial lead sensing threshold (millivolts)
Measured: Over 15 month follow up
Atrial lead impedance threshold (Ohms)
Measured: Over 15 month follow up
Atrial Fibrillation Severity Scale Version 2.0
Change in quality of life. The Atrial Fibrillation Severity Scale (AFSS) is composed of 19 items investigating four domains:
- AF burden (comprised of AF frequency + AF duration + AF severity): score range is 3-10, higher score = greater burden
- Health care utilization: score range is 0-7 for each question, higher score = more utilization
- Symptoms: score range is 0-35, higher score = greater symptom severity
- Global well-being: score range is 1-10, higher score = better quality of life
Measured: Over 15 month follow up
EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)
Change in quality of life. The EQ-5D-3L is a standardized instrument to assess generic health-related quality of life and contains questions on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of the five dimension, respondents are offered three response categories (no problems, some problems, extreme problems), leading to 243 possible health states. These health states are then converted into index based values (utilities) ranging from 0 to 1 by applying a valuation algorithm. The EQ-5D instrument includes a visual analogue scale (VAS), on which the patient is asked to score his/her current health state between 0 (worst imaginable health state) and 100 (best imaginable health state).
Measured: Over 15 month follow up
Hospitalization or urgent outpatient visit for atrial fibrillation
Measured: Within 15 months follow-up post pacemaker
Hospitalization or urgent outpatient visit for heart failure
Measured: Within 15 months follow-up post pacemaker
Cerebrovascular accident
Measured: Within 15 months follow-up post pacemaker
Atrial Fibrillation Ablation
Measured: Within 15 months follow-up post pacemaker
New start or up-titration of medications for the primary diagnosis of atrial fibrillation
Measured: Within 15 months follow-up post pacemaker
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start28 May 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Infeld, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153291
- Sponsor's protocol ID
- 00001532
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrically Guided Bachmann's Bundle Pacing Pilot Study: A Novel Lead Placement Strategy With Potential Antiarrhythmic Benefits
- ClinicalTrials.gov ID
- NCT05153291
- Acronym / sponsor ID
- 00001532
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Dec 2021 (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.
Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bachmann's bundle area pacing | Experimental | Procedure: Bachmann's bundle lead placementLead placement in Bachmann's bundle area |
| Right atrial appendage pacing | Active comparator | Procedure: Right atrial appendage lead placementLead placement in the right atrial appendage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is >18 years old
- Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
- Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)
- Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires
Key exclusion criteria (8 listed)
- Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
- Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
- Subject has resting spontaneous sinus rate >85 beats-per-minute
- Subject has left ventricular ejection fraction <45%
- Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
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 bundle lead placementAtrial lead placement at Bachmann's bundle area | Procedure or surgery | Bachmann's bundle area pacing |
| Right atrial appendage lead placementAtrial lead placement in the right atrial appendage | Procedure or surgery | Right atrial appendage pacing |
Primary outcome
Atrial arrhythmia burden from pacemaker counters
Time frame: Over 15 month follow up
Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.
14 secondary outcomes
Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups
Time frame: At implant
Atrial lead procedure time
Time frame: At implant
Atrial lead fluoroscopy time
Time frame: At implant
Atrial lead complications
Time frame: Over 15 month follow up
Atrial lead capture threshold (Volts)
Time frame: Over 15 month follow up
Atrial lead sensing threshold (millivolts)
Time frame: Over 15 month follow up
Atrial lead impedance threshold (Ohms)
Time frame: Over 15 month follow up
Atrial Fibrillation Severity Scale Version 2.0
Time frame: Over 15 month follow up
EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)
Time frame: Over 15 month follow up
Hospitalization or urgent outpatient visit for atrial fibrillation
Time frame: Within 15 months follow-up post pacemaker
Hospitalization or urgent outpatient visit for heart failure
Time frame: Within 15 months follow-up post pacemaker
Cerebrovascular accident
Time frame: Within 15 months follow-up post pacemaker
Atrial Fibrillation Ablation
Time frame: Within 15 months follow-up post pacemaker
New start or up-titration of medications for the primary diagnosis of atrial fibrillation
Time frame: Within 15 months follow-up post pacemaker
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No. De-identified data upon reasonable request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bachmann's bundle lead placement and Right atrial appendage lead placement in people with Atrial Fibrillation, run by University of Vermont at 1 site in United States.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial arrhythmia burden from pacemaker counters (time frame: Over 15 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2022.