Micra Transcatheter Pacing System Continued Access Study Protocol

Bradycardia Clinical Trial

Official title:

Medtronic Micra Transcatheter Pacing System Continued Access Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488681
• Other study ID #: Micra CA
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: March 16, 2018
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Micra Pacemaker Implant

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
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	Baptist Heart Specialists	Jacksonville	Florida
United States	Mid America Heart Institute	Kansas City	Missouri
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	North Shore LIJ Health System	Manhasset	New York
United States	Baptist Hospital of Miami	Miami	Florida
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Vanderbilt University Medical Center Heart and Vascular Institute	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	NYU Langone Medical Center	New York	New York
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	The Valley Hospital	Ridgewood	New Jersey
United States	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Micra system and/or procedure-related complication rate	3 months post last follow up