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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Micra Transcatheter Pacing Study
Secondary ID [1] 0 0
Micra
Universal Trial Number (UTN)
Trial acronym
Linked study record

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 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Micra Pacemaker Implant

Experimental: Micra Pacemaker Implant -


Treatment: Devices: Micra Pacemaker Implant


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Complications - Micra system and/or procedure related major complication free rate at 6-months post-implant.
Timepoint [1] 0 0
Implant to 6 Months Post Implant
Primary outcome [2] 0 0
Pacing Capture Threshold - 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.
Timepoint [2] 0 0
6 Months Post Implant
Secondary outcome [1] 0 0
Ventricular Capture Management Threshold - 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.
Timepoint [1] 0 0
6 Months Post Implant
Secondary outcome [2] 0 0
Rate Response Operation of Micra - 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.
Timepoint [2] 0 0
3 Months and 6 Months Post Implant (combined analysis)

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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandria Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Connecticut
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Florida
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Georgia
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Iowa
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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Oregon
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Austria
State/province [20] 0 0
Linz
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
China
State/province [22] 0 0
Beijing
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha
Country [24] 0 0
Denmark
State/province [24] 0 0
København
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France
State/province [25] 0 0
Bordeaux
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Greece
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Heraklion
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Hungary
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Budapest
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India
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Hyderabad
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India
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New Delhi
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Italy
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Pisa
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Japan
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Osaka
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Japan
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Shinagawa-Ku
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Japan
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Tokyo
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Japan
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Yokohama
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Malaysia
State/province [35] 0 0
Kuala Lumpur
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Netherlands
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Amsterdam
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Netherlands
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Eindhoven
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Netherlands
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Nieuwegein
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Serbia
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Belgrade
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South Africa
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Cape Town
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Spain
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Barcelona
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United Kingdom
State/province [42] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02004873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dwight Reynolds
Address 0 0
University of Oklahoma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications