Left Bundle Branch Area Mapping for Conduction System Pacing

Left Bundle-Branch Block Clinical Trial

Official title:

Left Bundle Branch Area Mapping for Conduction System Pacing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884359
• Other study ID #: SEMC
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: Michael Orlov, MD, PhD
• Phone: 617-789-3187
• Email: Michael.Orlov[@]steward.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Bundle-Branch Block
• Left Bundle-Branch Block
• Pacemaker DDD

Intervention

Diagnostic Test:
• 3D 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.

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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: — View 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 Arrhy — View 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroanatomical characteristics of the target area for Left Bundle lead implantation	Electroanatomical metrics	Through study completion, an average of 1 year