Micra Study - to evaluate the safety and effectiveness of the Micra pacemaker and to assess its long-term performance.
- Conditions
- Health Condition 1: null- Subjects who have a Class I or II indication forimplantation of a single chamber ventricularpacemaker according to ACC/AHA/HRS 2008guidelines and any national guidelines.
- Registration Number
- CTRI/2015/01/005445
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 780
Subjects who have a Class I or II indication for implantation of a single chamber pacemaker
according to ACC/AHA/HRS 2008 guidelines and any national guidelines
• Subjects who are able and willing to undergo the study requirements
• Subjects who are geographically stable and are available for follow-up at the investigative site
through the duration of the study
• Subjects who are at least 18 years of age (or older, if required by local law)
Subjects with current implantation of an implantable cardioverter defibrillator (ICD), implantable
pulse generator (IPG), cardiac resynchronization therapy (CRT), neurostimulator or any other
chronically implanted device which uses current in the body. Note that a temporary pacing wire is
allowed.
• Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist
device (LVAD)
• Subjects who are morbidly obese and physician believes telemetry communication of 5 inches
(12.7 cm) could not be obtained with programmer head
• Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer
sheath or implant on the right side of the heart (for example, due to obstructions or severe
tortuosity) in the opinion of the implanter
• Subjects who are considered as unable to tolerate an urgent sternotomy
• Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
• Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated
• Patient with an expected life expectancy shorter than primary endpoint duration (i.e. 12 months).
• Subjects who are currently enrolled or planning to participate in a potentially confounding drug or
device trial during the course of this study. Co-enrollment in concurrent trials is only allowed
provided when document pre-approval is obtained from the Medtronic study manager.
• Pregnant women, or women of child bearing potential and who are not on a reliable form of birth
control
• Patient with exclusion criteria required by local law (e.g. age, breast feeding, etc.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demonstrate that the freedom from acute major complications related the Micra technology at 30- <br/ ><br>days post-implant is greater than 85% <br/ ><br>â?¢ Demonstrate that the freedom from chronic major complications related to the Micra technology at <br/ ><br>12-months is greater than 90% <br/ ><br>â?¢ Demonstrate that the percentage of subjects with an adequate pacing capture threshold at 6- <br/ ><br>months post-implant exceeds 80%.Timepoint: 1) 30 days Post Implant <br/ ><br>2) 6 months Post Implant
- Secondary Outcome Measures
Name Time Method Demonstrate the rate response operation of the Micra system. <br/ ><br>â?¢ Demonstrate the accuracy of Micra ventricular capture management pacing thresholds compared <br/ ><br>to manual pacing capture thresholds.Timepoint: 12 months