Left Bundle-Branch Block, Pacemaker DDD
Conditions
Keywords
left bundle branch block, pacemaker, physiologic stimulation
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.
Interventions
DIAGNOSTIC_TEST3D Electroanatomical Mapping (NavX)
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.
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroanatomical characteristics of the target area for Left Bundle lead implantation | Through study completion, an average of 1 year | Electroanatomical metrics |
Countries
United States
Contacts
CONTACTMichael Orlov, MD, PhD
CONTACTKarina Demchuk, BS
PRINCIPAL_INVESTIGATORMichael Orlov, MD, PhD
Steward St. Elizabeth's Medical Center of Boston, Inc.
Outcome results
None listed