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Micra Transcatheter Pacing System Continued Access Study Protocol

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micra Pacemaker Implant
Sponsored by
Medtronic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Yale University
  • Baptist Heart Specialists
  • Baptist Hospital of Miami
  • Emory University
  • Iowa Heart Center
  • Michigan Heart
  • Minneapolis Heart Institute Foundation
  • CentraCare Heart and Vascular Center
  • Mid America Heart Institute
  • Morristown Memorial Hospital
  • The Valley Hospital
  • North Shore LIJ Health System
  • NYU Langone Medical Center
  • Duke University Medical Center
  • Cleveland Clinic
  • The Ohio State University
  • University of Oklahoma Health Science Center
  • Oklahoma Heart Hospital Research Foundation
  • Providence Health and Services
  • Lancaster General Hospital
  • University of Pittsburgh Medical Center UPMC Presbyterian
  • Lankenau Institute for Medical Research
  • The Stern Cardiovascular Foundation
  • Vanderbilt University Medical Center Heart and Vascular Institute
  • Baylor Research Institute
  • CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
  • University of Virginia Medical Center
  • Aurora Cardiovascular Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micra Pacemaker Implant

Arm Description

Micra Pacemaker Implant

Outcomes

Primary Outcome Measures

Complications
Micra system and/or procedure-related complication rate

Secondary Outcome Measures

Full Information

First Posted
June 18, 2015
Last Updated
March 16, 2018
Sponsor
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02488681
Brief Title
Micra Transcatheter Pacing System Continued Access Study Protocol
Official Title
Medtronic Micra Transcatheter Pacing System Continued Access Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micra Pacemaker Implant
Arm Type
Experimental
Arm Description
Micra Pacemaker Implant
Intervention Type
Device
Intervention Name(s)
Micra Pacemaker Implant
Primary Outcome Measure Information:
Title
Complications
Description
Micra system and/or procedure-related complication rate
Time Frame
3 months post last follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Baptist Heart Specialists
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
CentraCare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
North Shore LIJ Health System
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Heart Hospital Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Providence Health and Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lankenau Institute for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
The Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center Heart and Vascular Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35025987
Citation
Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.
Results Reference
derived
PubMed Identifier
33428248
Citation
El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.
Results Reference
derived
PubMed Identifier
32763431
Citation
Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.
Results Reference
derived

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Micra Transcatheter Pacing System Continued Access Study Protocol

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