Micra Transcatheter Pacing Study

December 18, 2017 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

744

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia
        • Princess Alexandria Hospital
  • Austria
      • Linz, Austria
        • Allgemeines Krankenhaus der Stadt Linz
  • Canada
      • Quebec, Canada
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Heart Institute
  • China
      • Beijing, China
        • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
  • Czechia
      • Praha, Czechia
        • Nemocnice Na Homolce
  • Denmark
      • København, Denmark
        • Rigshospitalet
  • France
      • Bordeaux, France
        • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Greece
      • Heraklion, Greece
        • University General Hospital of Heraklion
  • Hungary
      • Budapest, Hungary
        • Magyar Honvédség Honvédkorház
  • India
      • Hyderabad, India
        • Care Hospitals
      • New Delhi, India
        • All India Institute of Medical Sciences
      • New Delhi, India
        • Govind Ballabh Pant Hospital
  • Italy
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
  • Japan
      • Osaka, Japan
        • National Cerebral and Cardiovascular Center
      • Shinagawa-Ku, Japan
        • Showa University Hospital
      • Tokyo, Japan
        • Kyorin University Hospital
      • Yokohama, Japan
        • Yokohama City University Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara - National Heart Institute
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum (AMC)
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis - Locatie Nieuwegein
  • Serbia
      • Belgrade, Serbia
        • Klinicki Centar Srbije
  • South Africa
      • Cape Town, South Africa
        • Groote Schuur Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Clínic de Barcelona
  • United Kingdom
      • Southampton, United Kingdom
        • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Heart Specialists
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322-1059
        • Emory University Hospital
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407-1195
        • Minneapolis Heart Institute Foundation
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart & Vascular Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Mid America Heart Institute
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Memorial Hospital
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore Lij Health System
      • New York, New York, United States, 10016-4303
        • NYU Langone Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
      • Oklahoma City, Oklahoma, United States, 73104-5033
        • University of Oklahoma Health Science Center (OUHSC)
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Health & Services
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster Heart & Vascular Research Institute
      • Pittsburgh, Pennsylvania, United States, 15213-2536
        • University of Pittsburgh Medical Center UPMC Presbyterian
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Institute for Medical Research
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Stern Cardiovascular Clinic
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Research Institute
      • Houston, Texas, United States, 77030
        • St. Luke's Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micra Pacemaker Implant
Device: Micra Pacemaker Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Complications
Time Frame: Implant to 6 Months Post Implant
Micra system and/or procedure related major complication free rate at 6-months post-implant.
Implant to 6 Months Post Implant
Pacing Capture Threshold
Time Frame: 6 Months Post Implant
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.
6 Months Post Implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular Capture Management Threshold
Time Frame: 6 Months Post Implant
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.
6 Months Post Implant
Rate Response Operation of Micra
Time Frame: 3 Months and 6 Months Post Implant (combined analysis)
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.
3 Months and 6 Months Post Implant (combined analysis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: Dwight Reynolds, University of Oklahoma
  • Study Chair: Philippe Ritter, Hôpital Haut-Lévêque

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Micra

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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