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Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National GuidelinesNCT02004873

Micra Transcatheter Pacing Study

A study testing Micra Pacemaker Implant in people with Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines, run by Medtronic Cardiac Rhythm and Heart Failure at 56 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Micra Pacemaker Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
744 participants
Where
56 sitesin 19 countries
Study dates
Nov 2013to May 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.).

Trial locations and contacts

56 sites in 19 countries.

56 sites in 19 countries

United States30 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322-1059

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Baylor Research Institute

    Dallas, Texas, 75226

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • The Stern Cardiovascular Clinic

    Germantown, Tennessee, 38138

  • St. Luke's Medical Center

    Houston, Texas, 77030

  • Baptist Heart Specialists

    Jacksonville, Florida, 32207

  • Mid America Heart Institute

    Kansas City, Missouri, 64111

  • Scripps

    La Jolla, California, 92037

  • Lancaster Heart & Vascular Research Institute

    Lancaster, Pennsylvania, 17604

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • North Shore LIJ Health System

    Manhasset, New York, 11030

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407-1195

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06520

  • NYU Langone Medical Center

    New York, New York, 10016-4303

  • University of Oklahoma Health Science Center (OUHSC)

    Oklahoma City, Oklahoma, 73104-5033

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213-2536

  • Providence Health & Services

    Portland, Oregon, 97225

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan4 sites

  • National Cerebral and Cardiovascular Center

    Osaka

  • Showa University Hospital

    Shinagawa-Ku

  • Kyorin University Hospital

    Tokyo

  • Yokohama City University Hospital

    Yokohama

Other trials in Japan

India3 sites

  • CARE Hospitals

    Hyderabad

  • All India Institute of Medical Sciences

    New Delhi

  • Govind Ballabh Pant Hospital

    New Delhi

Other trials in India

Netherlands3 sites

  • Academisch Medisch Centrum (AMC)

    Amsterdam

  • Catharina Ziekenhuis

    Eindhoven

  • St. Antonius Ziekenhuis - Locatie Nieuwegein

    Nieuwegein

Other trials in Netherlands

Canada2 sites

  • Montreal Heart Institute

    Montreal, Quebec

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec

Other trials in Canada

Australia1 site

  • Princess Alexandria Hospital

    Woolloongabba, Queensland

Other trials in Australia

Austria1 site

  • Allgemeines Krankenhaus der Stadt Linz

    Linz

Other trials in Austria

China1 site

  • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

Other trials in China

Czechia1 site

  • Nemocnice Na Homolce

    Prague

Other trials in Czechia

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

France1 site

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    Bordeaux

Other trials in France

Greece1 site

  • University General Hospital of Heraklion

    Heraklion

Other trials in Greece

Hungary1 site

  • Magyar Honvédség Honvédkorház

    Budapest

Other trials in Hungary

Italy1 site

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    Pisa

Other trials in Italy

Malaysia1 site

  • Institut Jantung Negara - National Heart Institute

    Kuala Lumpur

Other trials in Malaysia

Serbia1 site

  • Klinicki Centar Srbije

    Belgrade

Other trials in Serbia

South Africa1 site

  • Groote Schuur Hospital

    Cape Town

Other trials in South Africa

Spain1 site

  • Hospital Universitari Clínic de Barcelona

    Barcelona

Other trials in Spain

United Kingdom1 site

  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

    Southampton

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Micra Pacemaker Implant
Keywords
pacemaker, leadless, single chamber

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micra Pacemaker ImplantDevice

Study groups in NCT02004873
Study groupRoleWhat they receive
Micra Pacemaker ImplantExperimentalNot described
Receives: Device: Micra Pacemaker Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Complications

    Micra system and/or procedure related major complication free rate at 6-months post-implant.

    Measured: Implant to 6 Months Post Implant

  2. 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.

    Measured: 6 Months Post Implant

Secondary outcomes (2)

  1. 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.

    Measured: 6 Months Post Implant

  2. 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.

    Measured: 3 Months and 6 Months Post Implant (combined analysis)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2015
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004873
Sponsor's protocol ID
Micra
Status last verified
Dec 2017
First submitted
3 Dec 2013
Last updated
17 Jan 2018
Data monitoring committee
Yes

Publications

  • Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.

    PubMed 35025987

  • El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.

    PubMed 33428248

  • Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

    PubMed 32763431

  • Tjong FVY, Beurskens NEG, de Groot JR, Waweru C, Liu S, Ritter P, Reynolds D, Wilde AAM, Knops RE; Micra Investigators. Health-related quality of life impact of a transcatheter pacing system. J Cardiovasc Electrophysiol. 2018 Dec;29(12):1697-1704. doi: 10.1111/jce.13726. Epub 2018 Oct 15.

    PubMed 30168233

  • El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Vinolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.

    PubMed 30103071

  • Okabe T, El-Chami MF, Lloyd MS, Buck B, Gornick CC, Moore JC, Augostini RS, Hummel JD. Leadless pacemaker implantation and concurrent atrioventricular junction ablation in patients with atrial fibrillation. Pacing Clin Electrophysiol. 2018 May;41(5):504-510. doi: 10.1111/pace.13312. Epub 2018 Apr 16.

    PubMed 29476660

  • Soejima K, Asano T, Ishikawa T, Kusano K, Sato T, Okamura H, Matsumoto K, Taguchi W, Stromberg K, Lande J, Kobayashi Y; Micra Transcatheter Pacing Study Group. Performance of Leadless Pacemaker in Japanese Patients vs. Rest of the World - Results From a Global Clinical Trial. Circ J. 2017 Oct 25;81(11):1589-1595. doi: 10.1253/circj.CJ-17-0259. Epub 2017 May 30.

    PubMed 28566657

  • Lloyd M, Reynolds D, Sheldon T, Stromberg K, Hudnall JH, Demmer WM, Omar R, Ritter P, Hummel J, Mont L, Steinwender C, Duray GZ. Rate adaptive pacing in an intracardiac pacemaker. Heart Rhythm. 2017 Feb;14(2):200-205. doi: 10.1016/j.hrthm.2016.11.016. Epub 2016 Nov 15.

    PubMed 27871854

  • Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA, Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. doi: 10.1056/NEJMoa1511643. Epub 2015 Nov 9.

    PubMed 26551877

  • Ritter P, Duray GZ, Steinwender C, Soejima K, Omar R, Mont L, Boersma LV, Knops RE, Chinitz L, Zhang S, Narasimhan C, Hummel J, Lloyd M, Simmers TA, Voigt A, Laager V, Stromberg K, Bonner MD, Sheldon TJ, Reynolds D; Micra Transcatheter Pacing Study Group. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J. 2015 Oct 1;36(37):2510-9. doi: 10.1093/eurheartj/ehv214. Epub 2015 Jun 4.

    PubMed 26045305

  • Ritter P, Duray GZ, Zhang S, Narasimhan C, Soejima K, Omar R, Laager V, Stromberg K, Williams E, Reynolds D; Micra Transcatheter Pacing Study Group. The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker. Europace. 2015 May;17(5):807-13. doi: 10.1093/europace/euv026. Epub 2015 Apr 7.

    PubMed 25855677

Questions about this trial

What is this clinical trial studying?

A study testing Micra Pacemaker Implant in people with Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines, run by Medtronic Cardiac Rhythm and Heart Failure at 56 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Japan, India, Netherlands, Canada and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Complications (time frame: Implant to 6 Months Post Implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004873, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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