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

NCT06798961 | Active Not Recruiting

• 1 other identifier: NMCSD.2024.0019
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiac death

  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

Study Arms (1)

All patients

Patients diagnosed with Accessory pathway between ages 18-40.

Procedure: Ablation; Procedure: Standard of care without ablation

Interventions

Ablation PROCEDURE

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

All patients

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.

All patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (6)

• 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.

  PMID: 26621650 BACKGROUND

• 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.

  PMID: 21147259 BACKGROUND

• 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.

  PMID: 23827401 BACKGROUND

• 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.

  PMID: 22532593 BACKGROUND

• 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.

  PMID: 22579340 BACKGROUND

• 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.

  PMID: 26399663 BACKGROUND

MeSH Terms

Conditions

Death; Death, Sudden, Cardiac; Wolff-Parkinson-White Syndrome; Pre-Excitation Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-01

Locations

US (1)