Left Bundle-Branch BlockNCT05884359
Left Bundle Branch Area Mapping for Conduction System Pacing
An observational study of Left Bundle-Branch Block and Pacemaker DDD, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial summary
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Left Bundle-Branch Block, Pacemaker DDD
- What is being tested?
- 3D Electroanatomical Mapping (NavX)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Dec 2028
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation for standard pacemaker indications at one location (Steward St. Elizabeth Medical Center).
Who may be able to join
- 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.
Who cannot join
- Recent MI-less than 3 months
- Recent Percutaneous Coronary Revascularization-less than 2 weeks
- Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month
- Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Michael Orlov, MD, PhD, 617-789-3187, Michael.Orlov@steward.org
About this study
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.
Read the detailed description
This is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. We will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. Several electro-anatomical characteristics will be measured during the lead placement into the Left Bundle Branch Area. Mapping will be performed with the pacing lead. We will collect electrocardiographic markers of successful and unsuccessful LBBA pacemaker implantation attempts and correlate them with electro-anatomical information.
- Conditions
- Left Bundle-Branch Block, Pacemaker DDD
- Being tested
- 3D Electroanatomical Mapping (NavX)
- Keywords
- left bundle branch block, pacemaker, physiologic stimulation
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Electroanatomical Mapping (NavX)Diagnostic test
Also called Implantation of a standard Left Bundle Area pacing lead and pacing device
To utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. Patients will undergo placement of standard Left Bundle Area pacing leads for routine indications, during the implantation procedure electro-anatomical map of the target area and neighboring tissues will be created. Map characteristics will be analyzed and used intra-operatively to assist with lead placement along with standard pacing metrics and standard X-ray criteria. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroanatomical characteristics of the target area for Left Bundle lead implantation
Electroanatomical metrics
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 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 Left Bundle-Branch BlockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Orlov, MD, PhD, Principal investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884359
- Sponsor's protocol ID
- SEMC
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Orlov MV, Jahangir A, McKelvey D, Armstrong J, Maslov M, Monin AJ, Koulouridis I, Casavant D, Wylie JV. His bundle pacing insights from electroanatomical mapping: Topography and pacing targets. J Cardiovasc Electrophysiol. 2020 Oct;31(10):2737-2743. doi: 10.1111/jce.14672. Epub 2020 Jul 23.
PubMed 32666617Orlov MV, Nikolaychuk M, Koulouridis I, Goldman A, Natan S, Armstrong J, Bhattacharya A, Hicks A, King M, Wylie J. Left bundle area pacing: Guiding implant depth by ring measurements. Heart Rhythm. 2023 Jan;20(1):55-60. doi: 10.1016/j.hrthm.2022.09.013. Epub 2022 Sep 21.
PubMed 36152975Orlov MV, Koulouridis I, Monin AJ, Casavant D, Maslov M, Erez A, Hicks A, Aoun J, Wylie JV. Direct Visualization of the His Bundle Pacing Lead Placement by 3-Dimensional Electroanatomic Mapping: Technique, Anatomy, and Practical Considerations. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006801. doi: 10.1161/CIRCEP.118.006801.
PubMed 30739495
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Mapping for Conduction System Pacing
- ClinicalTrials.gov ID
- NCT05884359
- Acronym / sponsor ID
- SEMC
- Conditions
- Left Bundle-Branch Block, Pacemaker DDD
- Keywords
- left bundle branch block, pacemaker, physiologic stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Jun 2023 (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.
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.
Detailed description
This is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. We will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. Several electro-anatomical characteristics will be measured during the lead placement into the Left Bundle Branch Area. Mapping will be performed with the pacing lead. We will collect electrocardiographic markers of successful and unsuccessful LBBA pacemaker implantation attempts and correlate them with electro-anatomical information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation for standard pacemaker indications at one location (Steward St. Elizabeth Medical Center).
Key inclusion criteria (1 listed)
- 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.
Key exclusion criteria (4 listed)
- Recent MI-less than 3 months
- Recent Percutaneous Coronary Revascularization-less than 2 weeks
- Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month
- Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker
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 |
|---|---|---|
| 3D Electroanatomical Mapping (NavX)Also: Implantation of a standard Left Bundle Area pacing lead and pacing deviceTo utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. Patients will undergo placement of standard Left Bundle Area pacing leads for routine indications, during the implantation procedure electro-anatomical map of the target area and neighboring tissues will be created. Map characteristics will be analyzed and used intra-operatively to assist with lead placement along with standard pacing metrics and standard X-ray criteria. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases. | Diagnostic test | – |
Primary outcome
Electroanatomical characteristics of the target area for Left Bundle lead implantation
Time frame: Through study completion, an average of 1 year
Electroanatomical metrics
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 21 Jul 2026.
- Results publication: PubMed 32666617Orlov MV, Jahangir A, McKelvey D, Armstrong J, Maslov M, Monin AJ, Koulouridis I, Casavant D, Wylie JV. His bundle pacing insights from electroanatomical mapping: Topography and pacing targets. J Cardiovasc Electrophysiol. 2020 Oct;31(10):2737-2743. doi: 10.1111/jce.14672. Epub 2020 Jul 23.
- Results publication: PubMed 36152975Orlov MV, Nikolaychuk M, Koulouridis I, Goldman A, Natan S, Armstrong J, Bhattacharya A, Hicks A, King M, Wylie J. Left bundle area pacing: Guiding implant depth by ring measurements. Heart Rhythm. 2023 Jan;20(1):55-60. doi: 10.1016/j.hrthm.2022.09.013. Epub 2022 Sep 21.
- Results publication: PubMed 30739495Orlov MV, Koulouridis I, Monin AJ, Casavant D, Maslov M, Erez A, Hicks A, Aoun J, Wylie JV. Direct Visualization of the His Bundle Pacing Lead Placement by 3-Dimensional Electroanatomic Mapping: Technique, Anatomy, and Practical Considerations. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006801. doi: 10.1161/CIRCEP.118.006801.
- Individual participant dataSharing planned: No
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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.
Michael Orlov, MD, PhD principal investigator
Steward St. Elizabeth's Medical Center of Boston, Inc.
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 Left Bundle-Branch Block and Pacemaker DDD, run by Steward St. Elizabeth's Medical Center of Boston, Inc. 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Jul 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 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?
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 Michael Orlov, MD, PhD (617-789-3187, Michael.Orlov@steward.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroanatomical characteristics of the target area for Left Bundle lead implantation (time frame: Through study completion, an average of 1 year). 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 NCT05884359, 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 21 Jul 2026.