LEADR
Research type
Research Study
Full title
Lead EvaluAtion for Defibrillation and Reliability (LEADR)
IRAS ID
294670
Contact name
Zachary whinnett
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Implantable cardioverter defibrillator (ICD) systems are indicated for patients who are at risk for sudden cardiac death, have exhibited life threatening tachyarrhythmia, or have compromised heart function associated with heart failure. Despite enhancements in design and technologies, the ICD lead is typically the most vulnerable component of the ICD system. To address needs for long term reliability, reduced defibrillation lead diameter, and ease of extraction for a defibrillation lead, Medtronic has developed the ‘Next Generation ICD lead’.
The LEADR study will evaluate the safety and efficacy of the Next Generation ICD lead in a clinical setting. Subjects indicated for implantation of a single or dual chamber ICD or a CRT-D and who meet all inclusion criteria and no exclusion criteria are eligible to receive this lead instead of a commercially available lead. Post implant, subjects will be followed at 3 months and every six-months thereafter for up to 3 years. The visits may include study system testing, non-invasive information download from the study system and X-rays.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0520
Date of REC Opinion
26 Oct 2021
REC opinion
Further Information Favourable Opinion