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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06798961
Acronym
LEAD-AP
Enrollment
1000
Registered
2025-01-29
Start date
2024-11-01
Completion date
2025-12-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

accessory pathway, ablation, cardiac death, Wolf Parkinson's white

Brief 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.

Interventions

PROCEDUREAblation

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

PROCEDUREStandard of care without ablation

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

Sponsors

United States Naval Medical Center, San Diego
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac death5 yearsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026