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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.
Brief TitleShort description of the protocol intended for the lay public. Include a brief statement of the study hypothesis.
This study has suspended participant recruitment.
Recruitment StatusIndicates the current stage of a clinical study and whether it is or will be open for enrollment.
Medtronic Cardiac Rhythm and Heart Failure
SponsorThe sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Information provided byThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information.
ClinicalTrials.gov IdentifierA unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.
First ReceivedThe First Received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry.
Last UpdatedThe Last Updated date is the most recent date that changes to a study record were submitted to ClinicalTrials.gov.
Last VerifiedThe Last Verified date is the most recent date that all of a clinical study's information on ClinicalTrials.gov was confirmed as accurate and current.
First Received DateThe First Received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry.
Last Updated DateThe Last Updated date is the most recent date that changes to a study record were submitted to ClinicalTrials.gov.
Start DateThe date that the enrollment of participants for a clinical study begins
Estimated Primary Completion Date The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.
Major Complications [ Time Frame: Implant to 6 Months Post Implant ] [ Designated as safety issue: ]
Micra system and/or procedure related major complication free rate at 6-months post-implant.
Pacing Capture Threshold [ Time Frame: 6 Months Post Implant ] [ Designated as safety issue: ]
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.
Current Primary Outcome Measures Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Same as current
Original Primary Outcome Measures Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Click [ HERE ] for a complete list of historical versions of study NCT02004873 on ClinicalTrials.gov Archive Site
Change Historyclick the link provided for a complete list of historical versions of study NCT02004873 on ClinicalTrials.gov Archive Site.
Ventricular Capture Management Threshold [ Time Frame: 6 Months Post Implant ] [ Designated as safety issue: ]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.
Rate Response Operation of Micra [ Time Frame: 3 Months and 6 Months Post Implant (combined analysis) ] [ Designated as safety issue: ]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.
Current Secondary Outcome Measures Secondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.
Same as current.
Original Secondary Outcome MeasuresSecondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.
Current Other Outcome MeasuresAny other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue.
Original Other Outcome MeasuresAny other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue.
Micra Transcatheter Pacing Study
Brief TitleProtocol title intended for the lay public.
Official TitlesOfficial name of the protocol provided by the study principal investigator or sponsor.
Brief SummaryShort description of the protocol intended for the lay public. Include a brief statement of the study hypothesis.
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
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
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.
Detailed DescriptionExtended description of the protocol, including more technical information.
Study TypeInterventional study in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.
Observational study in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.
Expanded Access records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track.
Study DesignTOOLTIP TOO ELABORATE
Target Follow-Up DurationFor Patient Registries, the anticipated time period over which each participant is to be followed. Provide a number and select a unit of time (years, months, weeks, days).
BiospecimenuSpecify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
ConditionPrimary disease or condition being studied, or focus of the study. Diseases or conditions should use the National Library of Medicine's Medical Subject Headings (MeSH) controlled vocabulary when possible.
InterventionFor all studies, and for expanded access records, specify the associated intervention(s). For interventional studies, at least one intervention must be specified. For observational studies, specify the intervention(s)/exposure(s) of interest, if any.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruiting StatusTOOLTIP TOO COMPLEX TO DISPLAY
Estimated EnrollmentNumber of subjects in the trial.
Completion DateFinal date on which data was (or is expected to be) collected.
Estimated Primary Completion DateThe date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.
- 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
- 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).
- 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
- 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,
Eligibility CriteriaPhysical gender of individuals who may participate in the protocol.
Minimum and/or maximum age of participants.
Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.
GenderBoth: both female and male participants are being studied
Female: only female participants are being studied
Male: only male participants are being studied
Minimum Age: 18 Years
Definition: Minimum age of participants. Provide a number and select a unit of time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no minimum age is indicated.
Definition: Maximum age of participants. Provide a number and a unit of time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no maximum age is indicated.
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsCentral Contact - Person providing centralized, coordinated recruitment information for the entire study.
Central Contact Backup - Person to contact if Central Contact is not available.
Overall Study Officials - Person(s) responsible for the overall scientific leadership of the protocol, including study principal investigator.
Australia, Austria, Canada, China, Czechia, Denmark, France, Greece, Hungary, India, Italy, Japan, Malaysia, Netherlands, Serbia, South Africa, Spain, United Kingdom, United States
Listed Location CountriesDESCRIPTION
NCT NumberA unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.
Other Study ID NumbersUnique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.
Has Data Monitoring CommitteeGGGGGGG
Responsible PartySponsor: the entity (e.g., corporation or agency) that initiates the study
Principal Investigator: the individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute
Sponsor-Investigator: the individual who both initiates and conducts the study
CollaboratorA collaborator is an organization other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis, or reporting.
StudyChair: Dwight Reynolds | University of Oklahoma
StudyChair: Philippe Ritter | Hôpital Haut-Lévêque
InvestigatorsThe person who both initiates and conducts the clinical study.
Information Provided ByThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information.
Verification DateDate the protocol information was last verified. Verification date is shown along with organization name on ClinicalTrials.gov to indicate to the public whether the information is being kept current, particularly recruiting status and contact information.