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NCT04863664 · ClinicalTrials.gov registry record · NA
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
A NA study of Tachyarrhythmia, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 998
- Enrollment target
- 20
- Study locations
NCT04863664 is a NA study of Tachyarrhythmia that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 998 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT04863664, a NA study of Tachyarrhythmia, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 998 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Defibrillation (RV Implant)
- DEVICE Defibrillation (LBBAP Implant)
Study Locations (20)
Ohio
- LEADR: TriHealth Hatton Research Institute - Cincinnati
- LEADR LBBAP: The Christ Hospital - Cincinnati
- LEADR: Cleveland Clinic - Cleveland
- LEADR LBBAP: The Ohio State University Wexner Medical Center - Columbus
Pennsylvania
- LEADR: Lehigh Valley Hospital - Cedar Crest - Allentown
- LEADR: Hospital of the University of Pennsylvania - Philadelphia
- LEADR LBBAP: Geisinger Wyoming Valley Medical Center - Wilkes-Barre
Missouri
- LEADR: Saint Luke's Mid America Heart Institute - Kansas City
- LEADR: Washington University School of Medicine - St Louis
Texas
- LEADR: Texas Cardiac Arrhythmia Research Foundation - Austin
- LEADR: Texas Health Fort Worth Hospital - Fort Worth
Alabama
- LEADR: Heart Center Research - Huntsville
California
- LEADR LBBAP: Torrance Memorial Medical Center - Torrance
Connecticut
- LEADR: Hartford Hospital - Hartford
Florida
- LEADR: University of South Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 998 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2025-11-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04863664
The ClinicalTrials.gov registry entry for NCT04863664 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 998 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tachyarrhythmia appearing as the primary indexed condition, and to 2 interventions - of which Defibrillation (RV Implant) is the first listed.
NCT04863664 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Ohio, Pennsylvania, Missouri.
Frequently Asked Questions
What is clinical trial NCT04863664 about?
NCT04863664 is a clinical study titled "Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)". 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...
What is the current status of trial NCT04863664?
This trial is currently completed. It is a NA study. The enrollment target is 998 participants. The study started on 2021-06-21. Estimated completion is 2025-11-06.
What conditions does trial NCT04863664 study?
This clinical trial studies the following conditions: Tachyarrhythmia.
What interventions are being tested in trial NCT04863664?
The interventions under investigation include: Defibrillation (RV Implant) (DEVICE), Defibrillation (LBBAP Implant) (DEVICE).
Who is sponsoring clinical trial NCT04863664?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04863664 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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