Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
Public ClinicalTrials.gov record NCT04863664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD Lead and is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population.
Study identification
- NCT ID
- NCT04863664
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 998 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 21, 2021 (Actual)
- Primary completion
- Sep 3, 2025 (Actual)
- Completion
- Nov 6, 2025 (Actual)
- Last update posted
- Dec 9, 2025
2021 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LEADR: Heart Center Research | Huntsville | Alabama | 35801 | — |
| LEADR LBBAP: Torrance Memorial Medical Center | Torrance | California | 90505 | — |
| LEADR: Hartford Hospital | Hartford | Connecticut | 06106 | — |
| LEADR: University of South Florida | Tampa | Florida | 33606 | — |
| LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | — |
| LEADR: Saint Luke's Mid America Heart Institute | Kansas City | Missouri | 64111 | — |
| LEADR: Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| LEADR: Lourdes Cardiology Services | Voorhees Township | New Jersey | 08034 | — |
| LEADR: Presbyterian Heart Group | Albuquerque | New Mexico | 87108 | — |
| LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health | Bay Shore | New York | 11030 | — |
| LEADR: TriHealth Hatton Research Institute | Cincinnati | Ohio | 45202 | — |
| LEADR LBBAP: The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| LEADR: Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| LEADR LBBAP: The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| LEADR: Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| LEADR: Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| LEADR LBBAP: Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| LEADR& LEADR LBBAP: Vanderbilt University medical Center | Nashville | Tennessee | 37232 | — |
| LEADR: Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| LEADR: Texas Health Fort Worth Hospital | Fort Worth | Texas | 76104 | — |
| LEADR & LEADR LBBAP: University of Virginia Medical Center | Charlottesville | Virginia | 22903 | — |
| LEADR & LEADR LBBAP: Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | — |
| LEADR LBBAP: Aurora St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04863664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04863664 live on ClinicalTrials.gov.