Micra Transcatheter Pacing Study

NCT ID: NCT02004873

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 744 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-05-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micra Pacemaker Implant

Group Type: EXPERIMENTAL

Micra Pacemaker Implant

Intervention Type: DEVICE

Interventions

Micra Pacemaker Implant

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dwight Reynolds

Role: STUDY_CHAIR

University of Oklahoma

Philippe Ritter

Role: STUDY_CHAIR

Hôpital Haut-Lévêque

Locations

Scripps

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Baptist Heart Specialists

Jacksonville, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, United States

Mid America Heart Institute

Kansas City, Missouri, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

North Shore LIJ Health System

Manhasset, New York, United States

NYU Langone Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Oklahoma Health Science Center (OUHSC)

Oklahoma City, Oklahoma, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Providence Health & Services

Portland, Oregon, United States

Lancaster Heart & Vascular Research Institute

Lancaster, Pennsylvania, United States

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

The Stern Cardiovascular Clinic

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Research Institute

Dallas, Texas, United States

St. Luke's Medical Center

Houston, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Princess Alexandria Hospital

Woolloongabba, Queensland, Australia

Allgemeines Krankenhaus der Stadt Linz

Linz, , Austria

Montreal Heart Institute

Montreal, Quebec, Canada

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

Québec, , Canada

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

Beijing, , China

Nemocnice Na Homolce

Prague, , Czechia

Rigshospitalet

Copenhagen, , Denmark

Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, , France

University General Hospital of Heraklion

Heraklion, , Greece

Magyar Honvédség Honvédkorház

Budapest, , Hungary

CARE Hospitals

Hyderabad, , India

All India Institute of Medical Sciences

New Delhi, , India

Govind Ballabh Pant Hospital

New Delhi, , India

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, , Italy

National Cerebral and Cardiovascular Center

Osaka, , Japan

Showa University Hospital

Shinagawa-Ku, , Japan

Kyorin University Hospital

Tokyo, , Japan

Yokohama City University Hospital

Yokohama, , Japan

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, , Malaysia

Academisch Medisch Centrum (AMC)

Amsterdam, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, , Netherlands

Klinicki Centar Srbije

Belgrade, , Serbia

Groote Schuur Hospital

Cape Town, , South Africa

Hospital Universitari Clínic de Barcelona

Barcelona, , Spain

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Countries

United States; Australia; Austria; Canada; China; Czechia; Denmark; France; Greece; Hungary; India; Italy; Japan; Malaysia; Netherlands; Serbia; South Africa; Spain; United Kingdom

References

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Reference Type: DERIVED

PMID: 35025987 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33428248 (View on PubMed)

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.

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PMID: 32763431 (View on PubMed)

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PMID: 30103071 (View on PubMed)

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.

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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.

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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.

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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.

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Other Identifiers

Micra

Identifier Type: -

Identifier Source: org_study_id