NCT06798961

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: United States Naval Medical Center, San Diego · Federal
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Cardiac Death
• Cardiac Death, Sudden
• Wolf Parkinson White Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-01-29
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States