Longitudinal Evaluation of Active-Duty Personnel with Accessory Pathways (LEAD-AP) (LEAD-AP)

March 11, 2025 updated by: Abiola Babawale, United States Naval Medical Center, San Diego
The investigators propose a secondary chart review using EMR data to identify risk factors for sudden cardiac death in active-duty members diagnosed with an accessory pathway between the ages of 18-40.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The LEAD-AP study is a dual arm retrospective observational cohort study (using existing records) to investigate the long-term outcomes of patients diagnosed with an accessory pathway during their military service.

Overall objective: Identifying additional risk factors associated with sudden cardiac death to help with risk stratification and guide ablation criteria for patients diagnosed with accessory pathways between the ages of 18-40.

Specific Aim/Research Question: The investigators will evaluate whether patients with an ablation have improved outcomes.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Active Duty between ages 18-40 who were diagnosed with an accessory pathway between 1/1/1990 - 5/30/2024.

Description

Inclusion Criteria:

  • Active Duty between ages 18-40 who were diagnosed with an accessory pathway between 1/1/1990 - 5/30/2024.

Exclusion Criteria:

  • Patient without the diagnosis of Wolf Parkinson's White (WPW) syndrome

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
Patients diagnosed with Accessory pathway between ages 18-40.
Procedure: Ablation
Patient treated with an ablation to eliminate the accessory conduction pathway in the heart.
Procedure: Standard of care without ablation
Patient diagnosed with accessory pathway but elected against cardiac ablation as a treatment option at the time of diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 5 years
The goal of LEAD AP is to investigate the long-term outcomes of patients diagnosed with an accessory pathway during their military service; with the goal of identifying additional risk factors associated with sudden cardiac death to help with risk stratification and guide ablation for patients diagnosed with accessory pathways between the ages of 18-40.
5 years

Collaborators and Investigators

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

Sponsor

United States Naval Medical Center, San Diego

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 (Actual)

November 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2024.0019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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