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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02004873
Registration number
NCT02004873
Ethics application status
Date submitted
3/12/2013
Date registered
9/12/2013
Date last updated
17/01/2018
Titles & IDs
Public title
Micra Transcatheter Pacing Study
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Scientific title
Micra Transcatheter Pacing Study
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Secondary ID [1]
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Micra
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Micra Pacemaker Implant
Experimental: Micra Pacemaker Implant -
Treatment: Devices: Micra Pacemaker Implant
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Complications
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Assessment method [1]
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Micra system and/or procedure related major complication free rate at 6-months post-implant.
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Timepoint [1]
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Implant to 6 Months Post Implant
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Primary outcome [2]
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Pacing Capture Threshold
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Assessment method [2]
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Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT <=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months <=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.
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Timepoint [2]
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6 Months Post Implant
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Secondary outcome [1]
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Ventricular Capture Management Threshold
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Assessment method [1]
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Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device's pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.
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Timepoint [1]
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6 Months Post Implant
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Secondary outcome [2]
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Rate Response Operation of Micra
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Assessment method [2]
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Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.
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Timepoint [2]
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3 Months and 6 Months Post Implant (combined analysis)
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2017
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Sample size
Target
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Accrual to date
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Final
744
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandria Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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- Woolloongabba
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Recruitment outside Australia
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United States of America
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California
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Linz
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Osaka
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Amsterdam
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Serbia
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Belgrade
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Cape Town
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Barcelona
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Cardiac Rhythm and Heart Failure
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02004873
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Contacts
Principal investigator
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Dwight Reynolds
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Address
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University of Oklahoma
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02004873
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