Micra Transcatheter Pacing Study
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Device: Micra Pacemaker Implant
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Micra Transcatheter Pacing Study|
- Major Complications [ Time Frame: Implant to 6 Months Post Implant ] [ Designated as safety issue: No ]Micra system and/or procedure related major complication free rate 6-months post-implant
- Pacing Capture Threshold Success [ Time Frame: 6-Months Post Implant ] [ Designated as safety issue: No ]Pacing capture threshold (PCT) at the 6-month post-implant visit where success is defined as PCT <=2 volts at 0.24 ms pulse width and the increase from implant is <=1.5 volts.
- Micra Ventricular Capture Management (VCMT) [ Time Frame: 6-Months Post Implant ] [ Designated as safety issue: No ]Percentage of subjects that have a VCMT that is within 0.5 Volts of the manual (auto decrement) PCT (0.24 ms pulse width) at the 6-month post-implant visit
- Rate Response [ Time Frame: 3-Months and 6-Months Post Implant ] [ Designated as safety issue: No ]The Micra sensor-indicated rate derived from the input of the accelerometer during the M-PREP treadmill test at the 3-month and 6-month follow-up visits
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
The study is expected to be conducted in up to 70 sites located around the world, including up to 35 sites in the United States (U.S.).Participating geographies may include countries such as the U.S, Europe, China, India, Malaysia, and Japan.
Up to 780 subjects will be enrolled (i.e. consented) to allow up to 720 subjects to be implanted enabling at least 600 subjects to be followed for at least 12-months post-implant.
There are two primary objectives in this study (one safety and one efficacy). The primary safety objective of the study is to evaluate major complications related to the Micra system or procedure. The primary safety endpoint will be evaluated at 6-months (183 days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, will also be evaluated six months post-implant. This study also has a separate long term safety objective that will provide additional long-term safety data following potential regulatory submissions.
All subjects will be followed until official study closure (official study closure is defined as when Medtronic and/or FDA requirements have been satisfied per the Clinical Investigational Plan and/or by a decision by Medtronic or regulatory authority).
Additionally, the Micra Accelerometer Sensor Sub-Study (MASS) is expected to be conducted at approximately 4 centers already active in the Micra study and is intended to include countries such as Austria, Spain, Hungary and France. Up to 40 subjects are expected to be enrolled in the Sub-Study. The purpose of the Sub-Study is to test feasibility for future enhancements in the Micra device functionalities.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004873
Show 56 Study Locations
|Study Chair:||Dwight Reynolds||University of Oklahoma|
|Study Chair:||Philippe Ritter||Hôpital Haut-Lévêque|