Micra Transcatheter Pacing Study
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/19/2018 |
Start Date: | November 2013 |
End Date: | May 2017 |
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra
Transcatheter Pacing System and to assess long term performance.
Transcatheter Pacing System and to assess long term performance.
The study is being conducted in 56 sites located around the world, including 30 sites in the
United States (U.S.).
Up to 780 subjects were planned to be enrolled (i.e. consented) to allow up to 720 subjects
to be implanted enabling at least 600 subjects to be followed for at least 12-months
post-implant.
There are two primary objectives in this study (one safety and one efficacy). The primary
safety objective of the study is to evaluate major complications related to the Micra system
or procedure. The primary safety endpoint was pre-specified to be evaluated at 6-months (183
days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, was also
pre-specified to be evaluated six months post-implant. This study also has a separate long
term safety objective that will provide additional long-term safety data following potential
regulatory submissions.
All subjects will be followed until official study closure (official study closure is defined
as when Medtronic and/or FDA requirements have been satisfied per the Clinical
Investigational Plan and/or by a decision by Medtronic or regulatory authority).
Additionally, the Micra Accelerometer Sensor Sub-Study (MASS) is being conducted at 4 centers
already active in the Micra study in Austria, Spain, Hungary and France. Forty (40) subjects
were enrolled in the Sub-Study, and enrollment in the Sub-Study was complete as of March 31,
2016. The purpose of the Sub-Study is to test feasibility for future enhancements in the
Micra device functionalities.
An algorithm was designed to sense the atrial contraction using the Micra accelerometer.
United States (U.S.).
Up to 780 subjects were planned to be enrolled (i.e. consented) to allow up to 720 subjects
to be implanted enabling at least 600 subjects to be followed for at least 12-months
post-implant.
There are two primary objectives in this study (one safety and one efficacy). The primary
safety objective of the study is to evaluate major complications related to the Micra system
or procedure. The primary safety endpoint was pre-specified to be evaluated at 6-months (183
days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, was also
pre-specified to be evaluated six months post-implant. This study also has a separate long
term safety objective that will provide additional long-term safety data following potential
regulatory submissions.
All subjects will be followed until official study closure (official study closure is defined
as when Medtronic and/or FDA requirements have been satisfied per the Clinical
Investigational Plan and/or by a decision by Medtronic or regulatory authority).
Additionally, the Micra Accelerometer Sensor Sub-Study (MASS) is being conducted at 4 centers
already active in the Micra study in Austria, Spain, Hungary and France. Forty (40) subjects
were enrolled in the Sub-Study, and enrollment in the Sub-Study was complete as of March 31,
2016. The purpose of the Sub-Study is to test feasibility for future enhancements in the
Micra device functionalities.
An algorithm was designed to sense the atrial contraction using the Micra accelerometer.
Inclusion Criteria:
- Subjects who have a Class I or II indication for implantation of a single chamber
ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and any national
guidelines
- Subjects who are able and willing to undergo the study requirements and are expected
to be geographically stable for the duration of the follow-up.
- Subjects who are at least 18 years of age (or older, if required by local law).
Exclusion Criteria:
- Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm). (Please note:
Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm) can now be
included in the study. Medtronic notified all sites on July 23, 2014 that the
restriction against pacemaker dependent subjects was lifted, following review of the
Early Performance Assessment.)
- Subject has an existing or prior pacemaker, ICD or CRT device implant.
- Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI)
in the 30 days prior to eligibility assessment.
- Subjects with current implantation of neurostimulator or any other chronically
implanted device which uses current in the body. Note that a temporary pacing wire is
allowed.
- Subjects with a 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 (12.7 cm) could not be obtained with programmer head.
- Subjects whose 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
severe tortuosity) in the opinion of the implanter.
- Subjects who are considered as unable to tolerate an urgent sternotomy
- Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
- Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
- Subjects with a life expectancy of less than 12- months.
- Subjects who are currently enrolled or planning to participate in a potentially
confounding drug or device trial during the course of this study. Coenrollment in
concurrent trials is only allowed when document pre-approval is obtained from the
Medtronic study manager.
- Pregnant women, or women of child bearing potential and who are not on a reliable form
of birth control.
- Subjects with exclusion criteria required by local law (e.g. age, breast feeding,
etc.).
We found this trial at
33
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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