A Study for the Continued Access of the Micra Transcatheter Pacing System

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Written authorization and/or consent per institution and geographical requirements
Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
Able and accessible for follow-up per study requirements
At least 18 years of age
Not enrolled in a concurrent drug and/or device study that may confound registry result

Exclusion Criteria

Has had an acute myocardial infraction (AMI) within 30 days of implant
Has implantation of neurostimulator or any other chronically implanted device which uses current in the body
Has mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD)
Is morbidly obese and physician believes telemetry communication of ≤ 5 inches (12.5 cm) could not be obtained with programmer head.
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
Has known intolerance to Nickel-Titanium (Nitinol) Alloy
A single dose of 1.0mg dexamethasone acetate may be contraindicated
Life expectancy less than 12 months
Enrolled in a concurrent drug and/or device study that may confound CA study results

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Yong-Mei Cha, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Yong-Mei Cha, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials