Micra Transcatheter Pacing Study. Version 1. 19th June 2013.
Research type
Research Study
Full title
Micra Transcatheter Pacing Study
IRAS ID
131804
Contact name
Mikayala King
Contact email
Sponsor organisation
Medtronic Inc.
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
Conventional pacemaker systems comprise a small electronic device implanted in the shoulder area of the chest which is connected to the heart via electrical leads threaded through specific veins. However, advances in technology have resulted in the miniaturisation of pacemaker electronics and battery components enabling the device to be implanted directly into the heart without the need for these leads. As a miniaturised system, the Micra system, is the suitable for patients who would otherwise receive a conventional “single chamber“ pacemaker.
The absence of electrical leads means that many of the recognised risks associated with conventional lead-based systems are eliminated, potentially offering significant risk-reduction benefits to patients whilst retaining established therapeutic and monitoring capabilities.
Based upon extensive pre-clincal work, the study will evaluate the safety and effectiveness of the Micra Transcatheter Pacing System in a clincal setting.
The procedure involves the insertion of a catheter (tube) system into a vein in the groin under standard hospital procedures. Specifically designed tools will then enable the Micra pacemaker device to be passed along the veins for positioning inside the heart. Post-implant, patients will attend for follow-up visits at one month, three months, six months, and six-monthly thereafter for up to 4.5 years. At each visit routine checks plus study-specific tests will be carried out. Visits, may include:
Chest X-rays.
Walking tests.
Quality of life questionnaires.For the first fifty patients enrolled globally, additional tests will be carried out as follows:
1. Extended electrical testing at the implant, 3 and 6 months.
2. Treadmill walk tests at 3 and 6 months.
3. 24 hour heart monitoring as the patient carries on day to day patient activities (1 and 6 months).The expected enrolment period is 25 months with study duration anticipated to be 4.5 years.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1741
Date of REC Opinion
6 Jan 2014
REC opinion
Further Information Favourable Opinion