Left Bundle Branch Area Mapping for Conduction System Pacing

June 14, 2023 updated by: Steward St. Elizabeth's Medical Center of Boston, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Recruiting
        • St. Elizabeth's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroanatomical characteristics of the target area for Left Bundle lead implantation
Time Frame: Through study completion, an average of 1 year
Electroanatomical metrics
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Michael Orlov, MD, PhD, Steward St. Elizabeth's Medical Center of Boston, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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