Left Bundle Branch Area Mapping for Conduction System Pacing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-88
SponsorSteward St. Elizabeth's Medical Center of Boston, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.
Disqualifiers
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 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
3D Electroanatomical Mapping (NavX)
Diagnostic testTo 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Electroanatomical characteristics of the target area for Left Bundle lead implantation
Electroanatomical metrics
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov