BradycardiaNCT02488681
Micra Transcatheter Pacing System Continued Access Study Protocol
A study testing Micra Pacemaker Implant in people with Bradycardia, run by Medtronic at 29 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Micra Pacemaker Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 29 sitesUnited States
- Study dates
- Jun 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Emory University
Atlanta, Georgia
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Baylor Research Institute
Dallas, Texas, 75204
Duke University Medical Center
Durham, North Carolina, 27710
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
Houston, Texas, 77030
Baptist Heart Specialists
Jacksonville, Florida
Mid America Heart Institute
Kansas City, Missouri, 64111
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Cedars-Sinai Medical Center
Los Angeles, California, 90048
North Shore LIJ Health System
Manhasset, New York, 11030
Baptist Hospital of Miami
Miami, Florida, 33176
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Vanderbilt University Medical Center Heart and Vascular Institute
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06510
NYU Langone Medical Center
New York, New York, 10016
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Providence Health and Services
Portland, Oregon, 97220
The Valley Hospital
Ridgewood, New Jersey, 07450
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
Iowa Heart Center
West Des Moines, Iowa, 50266
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: Medtronic Micra Transcatheter Pacing System Continued Access 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).
Read the 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.
- Conditions
- Bradycardia
- Being tested
- Micra Pacemaker Implant
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micra Pacemaker ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Micra Pacemaker Implant | Experimental | Micra Pacemaker Implant Receives: Device: Micra Pacemaker Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Micra system and/or procedure-related complication rate
Measured: 3 months post last follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488681
- Sponsor's protocol ID
- Micra CA
- Status last verified
- Mar 2018
- First submitted
- 18 Jun 2015
- Last updated
- 12 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 35025987El-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.
PubMed 33428248Garg 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.
PubMed 32763431
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Micra Transcatheter Pacing System Continued Access Study
- ClinicalTrials.gov ID
- NCT02488681
- Acronym / sponsor ID
- Micra CA
- Conditions
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 3 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micra Pacemaker Implant | Experimental | Device: Micra Pacemaker ImplantMicra Pacemaker Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micra Pacemaker Implant | Device | Micra Pacemaker Implant |
Primary outcome
Complications
Time frame: 3 months post last follow up
Micra system and/or procedure-related complication rate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35025987Piccini 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.
- Derived from this study: PubMed 33428248El-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.
- Derived from this study: PubMed 32763431Garg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micra Pacemaker Implant in people with Bradycardia, run by Medtronic at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 3 months post last follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488681, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.