Micra Transcatheter Pacing System Continued Access Study Protocol
Medtronic Micra Transcatheter Pacing System Continued Access Study
1 other identifier
interventional
285
1 country
29
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
January 3, 2018
CompletedApril 12, 2018
March 1, 2018
1.1 years
June 18, 2015
December 4, 2017
March 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Complications
Micra system and/or procedure-related complication rate
3 months post last follow up
Study Arms (1)
Micra Pacemaker Implant
EXPERIMENTALMicra Pacemaker Implant
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (29)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Yale University
New Haven, Connecticut, 06510, United States
Baptist Heart Specialists
Jacksonville, Florida, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Emory University
Atlanta, Georgia, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303, United States
Mid America Heart Institute
Kansas City, Missouri, 64111, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
North Shore LIJ Health System
Manhasset, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120, United States
Providence Health and Services
Portland, Oregon, 97220, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center Heart and Vascular Institute
Nashville, Tennessee, 37232, United States
Baylor Research Institute
Dallas, Texas, 75204, United States
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
Related Publications (3)
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.
PMID: 35025987DERIVEDEl-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.
PMID: 33428248DERIVEDGarg 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.
PMID: 32763431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Micra CA Study Manager
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
July 2, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
April 12, 2018
Results First Posted
January 3, 2018
Record last verified: 2018-03