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Active, Not Recruiting

NCT Number: NCT06798961

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Death Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiac Death, Sudden Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Excitation Syndromes Wolf Parkinson White Syndrome Wolff-Parkinson-White Syndrome

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablation

Procedure

Patient treated with an ablation to eliminate the accessory conduction pathway in the heart.

Standard of care without ablation

Procedure

Patient diagnosed with accessory pathway but elected against cardiac ablation as a treatment option at the time of diagnosis.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Acronym: LEAD-AP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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