Clinical trial NCT05884359: Left Bundle Branch Area Mapping for Conduction System Pacing
Official title: Left Bundle Branch Area Mapping for Conduction System Pacing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Bundle-Branch Block
Pacemaker DDD
Keywords: left bundle branch block
pacemaker
physiologic stimulation
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Electroanatomical characteristics of the target area for Left Bundle lead implantation
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Michael Orlov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Orlov 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.
citation: Orlov 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.