Micra Transcatheter Pacing System Continued Access Study Protocol

Completed · Not applicable

Conditions studied: Bradycardia

In brief

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).

Key facts

Study ID: NCT02488681
Run by: Medtronic
People needed: 285
Starts: 2015-06-01
Expected to finish: 2016-07-01
Last updated by the study team: 2018-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Cedars-Sinai Medical Center — Los Angeles, California, United States
Yale University — New Haven, Connecticut, United States
Baptist Heart Specialists — Jacksonville, Florida, United States
Baptist Hospital of Miami — Miami, Florida, United States
Emory University — Atlanta, Georgia, United States
Iowa Heart Center — West Des Moines, Iowa, 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
NYU Langone Medical Center — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital Research Foundation — Oklahoma City, Oklahoma, United States
Providence Health and Services — Portland, Oregon, United States
Lancaster General Hospital — Lancaster, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
The Stern Cardiovascular Foundation — Germantown, Tennessee, United States
Vanderbilt University Medical Center Heart and Vascular Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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