An observational study in Left Bundle-Branch Block and Pacemaker DDD, sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc. · Observational
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.
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.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 30 is below the median of 162 across 33 observational studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Steward St. Elizabeth's Medical Center of Boston, Inc. is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
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Exclusion Criteria:
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.
Also known as: Implantation of a standard Left Bundle Area pacing lead and pacing device
Electroanatomical characteristics of the target area for Left Bundle lead implantation
Electroanatomical metrics
Time frame: Through study completion, an average of 1 year
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for Dec 2028, 66 months after the start.
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Steward St. Elizabeth's Medical Center of Boston, Inc.