Health Condition 1: null- Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines.
Conditions
Interventions
Intervention1: MicraTM Implantable Device and Transfemoral Catheter Delivery System: The Micra Transcatheter Pacing System is a miniaturized (2g, 0.8cc) single chamber implantable
pacemaker that provi
downloaded on the standard Medtronic 2090 programmer (system component)
â?¢ Micra Holter (accessory component)
The implanted patient will be in teh study for 5 years depending on their enrollment
Cont
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that the freedom from acute major complications related the Micra technology at 30- days post-implant is greater than 85% â?¢ Demonstrate that the freedom from chronic major complications related to the Micra technology at 12-months is greater than 90% â?¢ Demonstrate that the percentage of subjects with an adequate pacing capture threshold at 6- months post-implant exceeds 80%.Timepoint: 1) 30 days Post Implant 2) 6 months Post Implant | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate the rate response operation of the Micra system. â?¢ Demonstrate the accuracy of Micra ventricular capture management pacing thresholds compared to manual pacing capture thresholds.Timepoint: 12 months | — |
Countries
China, India, Japan, Malaysia, United States of America
Contacts
Public ContactHaresh Sachanandani
India Medtronic Pvt. Ltd.
Outcome results
None listed