LEADR LBBAP
Research type
Research Study
Full title
Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
IRAS ID
338629
Contact name
Zachary Whinnett
Contact email
Sponsor organisation
Medtronic Bakken Research Center B.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 30 days
Research summary
Implantable cardioverter defibrillator (ICD), or Cardiac Resynchronization Therapy – Defibrillator (CRT-D), are medical devices that are used for patients who are at risk for sudden cardiac death, have exhibited life threatening tachyarrhythmia, or have compromised heart function associated with heart failure.
An ICD or CRT-D works by sending electrical signals to help the heart maintain a steady beat. These devices also sense when the heart is beating in a dangerous way and can send an electric current to re-set the heart to a normal rhythm systems.
Despite enhancements in design and technologies, the ICD lead is typically the most vulnerable component of the ICD system. To address this, Medtronic has developed the ‘Next Generation ICD lead’. This new design allows for more flexibility and the narrower lead allows for catheter delivery.
The LEADR LBBAP study will evaluate the safety and performance of the Next Generation ICD Lead, which is normally placed in the right ventricular of the hear, but during this study will be placed within the left bundle branch area as an alternative approach.
REC name
South East Scotland REC 02
REC reference
24/SS/0073
Date of REC Opinion
17 Oct 2024
REC opinion
Further Information Favourable Opinion