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Micra Transcatheter Pacing System Continued Access Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488681
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : January 3, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic

Study Description
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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).

Condition or disease Intervention/treatment Phase
Bradycardia Device: Micra Pacemaker Implant Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medtronic Micra Transcatheter Pacing System Continued Access Study
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Micra Pacemaker Implant
Micra Pacemaker Implant
 Device: Micra Pacemaker Implant


Outcome Measures
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Primary Outcome Measures :
  1. Complications [ Time Frame: 3 months post last follow up ]
    Micra system and/or procedure-related complication rate


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488681


Locations
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Sponsors and Collaborators
Medtronic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT02488681    
Other Study ID Numbers: Micra CA
First Posted: July 2, 2015    Key Record Dates
Results First Posted: January 3, 2018
Last Update Posted: April 12, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes