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ClinicalTrials.gov Identifier: NCT05884359
Recruitment Status : **RECRUITING NOW**
First Posted : June 1, 2023
Last Update Posted : June 15, 2023
Sponsor:
Information provided by (Responsible Party):
Steward St. Elizabeth’s Medical Center of Boston, Inc.
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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.
Left Bundle-Branch Block Pacemaker DDD
Diagnostic Test: 3D Electroanatomical Mapping (NavX)
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.
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Study Type :
Observational
Estimated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Left Bundle Branch Area Mapping for Conduction System Pacing
Estimated Study Start Date :
June 2023
Estimated Primary Completion Date :
June 1, 2024
Estimated Study Completion Date :
December 31, 2024
Resource links provided by the National Library of Medicine
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Intervention Details:
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.
Other Name: Implantation of a standard Left Bundle Area pacing lead and pacing device
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Primary Outcome Measures :
Electroanatomical characteristics of the target area for Left Bundle lead implantation [ Time Frame: Through study completion, an average of 1 year ]
Electroanatomical metrics
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years to 88 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Non-Probability Sample
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).
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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05884359
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St. Elizabeth’s Medical Center
Boston, Massachusetts, United States, 02135
Contact: Michael Orlov, MD, PhD   617-789-3187   Michael.Orlov@steward.org  Â
Steward St. Elizabeth’s Medical Center of Boston, Inc.
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Principal Investigator:
Michael Orlov, MD, PhD
Steward St. Elizabeth’s Medical Center of Boston, Inc.
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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 Arrhythm Electrophysiol. 2019 Feb;12(2):e006801. doi: 10.1161/CIRCEP.118.006801.
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Responsible Party:
Steward St. Elizabeth’s Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT05884359 Â Â
Other Study ID Numbers:
SEMC
First Posted:
June 1, 2023 Â Â Key Record Dates
Last Update Posted:
June 15, 2023
Last Verified:
May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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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
Keywords provided by Steward St. Elizabeth’s Medical Center of Boston, Inc.:
left bundle branch blockpacemakerphysiologic stimulation
Additional relevant MeSH terms:
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Bundle-Branch BlockHeart BlockArrhythmias, CardiacHeart Diseases
Cardiovascular DiseasesCardiac Conduction System DiseasePathologic Processes
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
