Micra Transcatheter Pacing System Continued Access Study Protocol
- Conditions
- Bradycardia
- Interventions
- Device: Micra Pacemaker Implant
- Registration Number
- NCT02488681
- Lead Sponsor
- Medtronic
- Brief Summary
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
- Detailed Description
The Micra CA study is a prospective, non-randomized, multi-center, study designed to allow controlled access of the Micra system when used as intended. All subjects enrolled in the Micra CA Study will be prospectively followed from implant, at 6-month intervals until study closure (i.e. FDA approval). Patients with previous or existing inactive implanted cardiac stimulation systems will have additional follow ups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Subject meets Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
- Subject able and accessible for follow-up per study requirements
- Subject is at least 18 years of age
- Patient is not enrolled in a concurrent drug and/or device study that may confound registry result.
- Subject has had an acute myocardial infraction (AMI) within 30 days of implant
- Subject has implantation of neurostimulator or any other chronically implanted device which uses current in the body
- Subject with 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 (12.5 cm) could not be obtained with programmer head.
- Subject who 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 sever tortuosity) in the opinion of the implanter
- Subjects with known intolerance to Nickel-Titanium (Nitinol) Alloy
- Subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated
- Subjects with life expectancy less than 12-months
- Subject is enrolled in a concurrent drug and/or device study that may confound CA study results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Micra Pacemaker Implant Micra Pacemaker Implant Micra Pacemaker Implant
- Primary Outcome Measures
Name Time Method Complications 3 months post last follow up Micra system and/or procedure-related complication rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Baptist Heart Specialists
🇺🇸Jacksonville, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
North Shore LIJ Health System
🇺🇸Manhasset, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Providence Health and Services
🇺🇸Portland, Oregon, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Vanderbilt University Medical Center Heart and Vascular Institute
🇺🇸Nashville, Tennessee, United States
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
🇺🇸Houston, Texas, United States
Aurora Cardiovascular Services
🇺🇸Milwaukee, Wisconsin, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Yale University
🇺🇸New Haven, Connecticut, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States