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
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.
Summary of Results
A total of 47 study sites were activated in the study, of which 45 sites enrolled at least one study participant. Participating geographies were Australia (4 activated sites), Greater China (5 activated sites), Malaysia (1 activated site), Singapore (1 activated site), Japan (3 activated sites), Canada (3 activated sites), and the United States (19 activated sites). In addition, in Europe, the study was conducted at 11 activated sites: Austria (1), Denmark (1), France (2), Germany (1), Italy (1), Portugal (1), Serbia (1), Spain (2) and UK (1).
Of 675 consented study participants, 18 exited without an implant attempt and 657 underwent an implant attempt of the investigational Model 093000 lead): the OmniaSecure™ SureScan™ MRI defibrillation lead (further referenced as “study lead”). Of the 657 study participants who underwent an implant attempt, 643 had a successful implant of the study lead and 14 did not. Of the 643 study participants with a successful implant, 513 remained in the study until study end, and 130 stopped study participation early.
For safety, the primary objective (6 months from implant) was to demonstrate that the rate of study participants without major complications related to the study lead at 6 months after implant is above 90%.
Out of the 657 study participants who had a study lead implant attempt, 19 had a total of 19 major complications adjudicated by the Clinical Events Committee related to the study lead through 6 months post-implant.
Based on the study analysis, the lower bound of the two-sided 95% credible interval for the study lead-related major complication free rate at 6 months post-implant was 95.2%. This is higher than the pre-set target value of 90%, so the primary safety goal was achieved.
The Stage 1 Safety Objective estimated the rate of study participants without study lead-related major complication at 3-months.
For this objective at 3 months from implant, there was no pre-set target value. The statistical analysis calculated a 95% credible interval to show the likely range of study participants without major complications from the study lead at 3 months after implant, based on the data available at the time of the statistical analysis and prior knowledge.
At 3 months after implantation, the estimated rate of study participants without major complications from the study lead was 97.4%, between 96% and 98.5% (95% Credible Interval), based on the study analysis.
In the analysis, all study participants who had a study lead implant attempt were included. There were 15 major study lead-related major complications in 15 study participants within 3 months after implant.
For the efficacy, the primary efficacy objective was to demonstrate that at least 88% of study participants are successfully shocked (i.e., defibrillated) at implant with the study lead. The objective will be achieved if the lower bound of the 95% credible interval for the percentage of study participants successfully defibrillated is greater than 88%.
Out of 97 study participants included in the defibrillation testing main analysis, 94 had successful defibrillation at implant, giving a success rate of 96.9% (94 out of 97). The statistical analysis showed a lower bound of 91%, which is above the target value of 88%, meaning the primary efficacy goal was achieved.
The LEADR Study was a global, prospective study designed to evaluate the safety and effectiveness of the study lead. The study successfully met its goals, confirming that the lead is safe for use, effective in achieving its intended purpose, and reliable in its performance.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