Cardiac DeathLEAD-APNCT06798961
Longitudinal Evaluation of Active-Duty Personnel with Accessory Pathways (LEAD-AP)
An observational study of Cardiac Death and Cardiac Death, Sudden, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Cardiac Death, Cardiac Death, Sudden, Wolf Parkinson White Syndrome
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Active Duty between ages 18-40 who were diagnosed with an accessory pathway between 1/1/1990 - 5/30/2024.
Who may be able to join
- Active Duty between ages 18-40 who were diagnosed with an accessory pathway between 1/1/1990 - 5/30/2024.
Who cannot join
- Patient without the diagnosis of Wolf Parkinson's White (WPW) syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
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.
Read the 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.
- Being tested
- Ablation, Standard of care without ablation
- Keywords
- accessory pathway, ablation, cardiac death, Wolf Parkinson's white
- Medical subject headings
- Death, Death, Sudden, Cardiac, Wolff-Parkinson-White Syndrome, Pre-Excitation Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Patient treated with an ablation to eliminate the accessory conduction pathway in the heart.
Standard of care without ablationProcedure or surgery
Patient diagnosed with accessory pathway but elected against cardiac ablation as a treatment option at the time of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients diagnosed with Accessory pathway between ages 18-40. Receives: Procedure: Ablation; Procedure: Standard of care without ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Nov 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Abiola Babawale, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798961
- Sponsor's protocol ID
- NMCSD.2024.0019
- Acronym
- LEAD-AP
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26621650Huang 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.
PubMed 21147259Cain 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.
PubMed 23827401Obeyesekere 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.
PubMed 22532593Pediatric 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.
PubMed 22579340Page 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.
PubMed 26399663
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Active-Duty Personnel with Accessory Pathways (LEAD-AP)
- ClinicalTrials.gov ID
- NCT06798961
- Acronym / sponsor ID
- LEAD-AP / NMCSD.2024.0019
- Keywords
- accessory pathway, ablation, cardiac death, Wolf Parkinson's white
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: Ablation, Procedure: Standard of care without ablationPatients diagnosed with Accessory pathway between ages 18-40. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Active Duty between ages 18-40 who were diagnosed with an accessory pathway between 1/1/1990 - 5/30/2024.
Key inclusion criteria (1 listed)
- Active Duty between ages 18-40 who were diagnosed with an accessory pathway between 1/1/1990 - 5/30/2024.
Key exclusion criteria (1 listed)
- Patient without the diagnosis of Wolf Parkinson's White (WPW) syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationPatient treated with an ablation to eliminate the accessory conduction pathway in the heart. | Procedure or surgery | All patients |
| Standard of care without ablationPatient diagnosed with accessory pathway but elected against cardiac ablation as a treatment option at the time of diagnosis. | Procedure or surgery | All patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 26621650Zipes 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.
- Background: PubMed 21147259Huang 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.
- Background: PubMed 23827401Cain 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.
- Background: PubMed 22532593Obeyesekere 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.
- Background: PubMed 22579340Pediatric 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.
- Background: PubMed 26399663Page 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Death and Cardiac Death, Sudden, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798961, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.