The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker
Why the study?
Does the Micra Transcatheter Pacing System provide safe and efficacious pacing in patients with an indication for a single-chamber ventricular pacemaker?
Population
Approximately 720 patients with an indication for implantation of a single-chamber ventricular pacemaker.
Comparison
Micra Transcatheter Pacing System. vs None.
Design
Cohort
Follow-up
6 months
Authors
Discussion
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Implication
Study design leaves open Micra safety and efficacy for single-chamber pacing; prospective data needed before adoption.
Key Points
- To evaluate the safety and efficacy of the Micra Transcatheter Pacing System, a novel miniaturized, leadless single-chamber pacemaker implanted directly within the heart.
- Prospective, multi-site, single-arm clinical trial (NCT02004873) enrolling approximately 720 patients across up to 70 centres worldwide.
- The miniaturized device is delivered via catheter through the femoral vein and secured directly into the right ventricle, eliminating subcutaneous device pockets and transvenous pacing leads.
- The primary safety objective is to demonstrate that the proportion of patients free from major device- or procedure-related complications at 6 months is significantly greater than 83%, benchmarked against historical data from 977 patients.
- The primary efficacy objective is to demonstrate that the percentage of patients achieving both low and stable electrical pacing thresholds at 6 months is significantly greater than 80%.
Structured PICO
Does the Micra Transcatheter Pacing System provide safe and efficacious pacing in patients with an indication for a single-chamber ventricular pacemaker?
P
Population
Approximately 720 patients with an indication for implantation of a single-chamber ventricular pacemaker.
I
Intervention
Micra Transcatheter Pacing System (a miniaturized totally endocardial single-chamber pacemaker delivered via catheter through the femoral vein and implanted directly inside the right ventricle).
C
Comparator
None (single-arm study, with safety performance benchmark based on a historical reference dataset of 977 subjects from 6 recent pacemaker studies).
O
Outcome
Percentage of patients free from major complications related to the Micra system or implant procedure (>83%) and percentage of patients with both low and stable thresholds (>80%) at 6-month post-implant.safety
The Micra Transcatheter Pacing Study is designed to evaluate the safety and efficacy of a novel miniaturized, totally endocardial pacemaker.
Cite This Study
Ritter et al. (2015) studied this question.