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Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

NCT04863664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 998

Last updated 2025-12-09

No results posted yet for this 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

  • Tachyarrhythmia

Interventions

DEVICE

Defibrillation (RV Implant)

Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

DEVICE

Defibrillation (LBBAP Implant)

Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • George Crossley, MD · Vanderbilt University (LEADR)

  • Pugazhendhi Vijayaraman, MD · Geisinger Medical Center (LEADR LBBAP)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2025-09-03
Completion
2025-11-06
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • Portugal
  • Serbia
  • Singapore
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863664 on ClinicalTrials.gov