Left Bundle Branch Area Mapping for Conduction System Pacing

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study ID
NCT05884359
Status
Recruiting
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Conditions

  • Left Bundle-Branch Block
  • Pacemaker DDD

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • 3D Electroanatomical Mapping (NavX) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Electroanatomical characteristics of the target area for Left Bundle lead implantation [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Elizabeth's Medical CenterBostonMassachusetts02135
Michael Orlov, MD, PhD
[email protected]
617-789-3187

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By research site
St. Elizabeth's Medical Center· Boston, MA

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