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

NCT ID: NCT06798961

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Cardiac Death Cardiac Death, Sudden Wolf Parkinson White Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All patients

Patients diagnosed with Accessory pathway between ages 18-40.

Ablation

Intervention Type PROCEDURE

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

Standard of care without ablation

Intervention Type PROCEDURE

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

Interventions

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Ablation

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Naval Medical Center, San Diego

FED

Sponsor Role lead

Responsible Party

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Abiola Babawale

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Naval Medical Center San Diego

San Diego, California, United States

Site Status

Countries

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United States

References

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Zipes DP, Link MS, Ackerman MJ, Kovacs RJ, Myerburg RJ, Estes NA 3rd; American Heart Association Electrocardiography and Arrhythmias Committee of Council on Clinical Cardiology, Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and American College of Cardiology. Eligibility and Disqualification Recommendations for Competitive Athletes With Cardiovascular Abnormalities: Task Force 9: Arrhythmias and Conduction Defects: A Scientific Statement From the American Heart Association and American College of Cardiology. Circulation. 2015 Dec 1;132(22):e315-25. doi: 10.1161/CIR.0000000000000245. Epub 2015 Nov 2. No abstract available.

Reference Type BACKGROUND
PMID: 26621650 (View on PubMed)

Huang SY, Hu YF, Chang SL, Lin YJ, Lo LW, Tuan TC, Lee PC, Li CH, Suenari K, Chao TF, Tai CT, Chiang CE, Chen SA. Gender differences of electrophysiologic characteristics in patients with accessory atrioventricular pathways. Heart Rhythm. 2011 Apr;8(4):571-4. doi: 10.1016/j.hrthm.2010.12.013. Epub 2010 Dec 13.

Reference Type BACKGROUND
PMID: 21147259 (View on PubMed)

Cain N, Irving C, Webber S, Beerman L, Arora G. Natural history of Wolff-Parkinson-White syndrome diagnosed in childhood. Am J Cardiol. 2013 Oct 1;112(7):961-5. doi: 10.1016/j.amjcard.2013.05.035. Epub 2013 Jul 2.

Reference Type BACKGROUND
PMID: 23827401 (View on PubMed)

Obeyesekere MN, Leong-Sit P, Massel D, Manlucu J, Modi S, Krahn AD, Skanes AC, Yee R, Gula LJ, Klein GJ. Risk of arrhythmia and sudden death in patients with asymptomatic preexcitation: a meta-analysis. Circulation. 2012 May 15;125(19):2308-15. doi: 10.1161/CIRCULATIONAHA.111.055350. Epub 2012 Apr 24.

Reference Type BACKGROUND
PMID: 22532593 (View on PubMed)

Pediatric and Congenital Electrophysiology Society (PACES); Heart Rhythm Society (HRS); American College of Cardiology Foundation (ACCF); American Heart Association (AHA); American Academy of Pediatrics (AAP); Canadian Heart Rhythm Society (CHRS); Cohen MI, Triedman JK, Cannon BC, Davis AM, Drago F, Janousek J, Klein GJ, Law IH, Morady FJ, Paul T, Perry JC, Sanatani S, Tanel RE. PACES/HRS expert consensus statement on the management of the asymptomatic young patient with a Wolff-Parkinson-White (WPW, ventricular preexcitation) electrocardiographic pattern: developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology Foundation (ACCF), the American Heart Association (AHA), the American Academy of Pediatrics (AAP), and the Canadian Heart Rhythm Society (CHRS). Heart Rhythm. 2012 Jun;9(6):1006-24. doi: 10.1016/j.hrthm.2012.03.050. Epub 2012 May 10. No abstract available.

Reference Type BACKGROUND
PMID: 22579340 (View on PubMed)

Page RL, Joglar JA, Caldwell MA, Calkins H, Conti JB, Deal BJ, Estes NA 3rd, Field ME, Goldberger ZD, Hammill SC, Indik JH, Lindsay BD, Olshansky B, Russo AM, Shen WK, Tracy CM, Al-Khatib SM; Evidence Review Committee Chairdouble dagger. 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2016 Apr 5;133(14):e506-74. doi: 10.1161/CIR.0000000000000311. Epub 2015 Sep 23. No abstract available.

Reference Type BACKGROUND
PMID: 26399663 (View on PubMed)

Other Identifiers

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NMCSD.2024.0019

Identifier Type: -

Identifier Source: org_study_id

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