Micra Transcatheter Pacing Study

NCT02004873 | Completed Results DMC

• 1 other identifier: Micra
• Study Type: interventional
• Target: 744
• Locations: 18 countries
• Sites: 55

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.

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

Keywords

pacemaker; leadless; single chamber

Outcome Measures

Primary Outcomes (2)

• Major Complications

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

  Implant to 6 Months Post Implant

• 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.

  6 Months Post Implant

Secondary Outcomes (2)

• Ventricular Capture Management Threshold

  6 Months Post Implant

• Rate Response Operation of Micra

  3 Months and 6 Months Post Implant (combined analysis)

Study Arms (1)

Micra Pacemaker Implant

EXPERIMENTAL

Device: Micra Pacemaker Implant

Interventions

Micra Pacemaker Implant DEVICE

Micra Pacemaker Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (56)

Scripps

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Baptist Heart Specialists

Jacksonville, Florida, 32207, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322-1059, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407-1195, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

North Shore LIJ Health System

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016-4303, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Science Center (OUHSC)

Oklahoma City, Oklahoma, 73104-5033, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Health & Services

Portland, Oregon, 97225, United States

Location

Lancaster Heart & Vascular Research Institute

Lancaster, Pennsylvania, 17604, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213-2536, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

The Stern Cardiovascular Clinic

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Research Institute

Dallas, Texas, 75226, United States

Location

St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

Princess Alexandria Hospital

Woolloongabba, Queensland, Australia

Location

Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

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

Québec, Canada

Location

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

Beijing, China

Location

Nemocnice Na Homolce

Prague, Czechia

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, France

Location

University General Hospital of Heraklion

Heraklion, Greece

Location

Magyar Honvédség Honvédkorház

Budapest, Hungary

Location

CARE Hospitals

Hyderabad, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

Govind Ballabh Pant Hospital

New Delhi, India

Location

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Italy

Location

National Cerebral and Cardiovascular Center

Osaka, Japan

Location

Showa University Hospital

Shinagawa-Ku, Japan

Location

Kyorin University Hospital

Tokyo, Japan

Location

Yokohama City University Hospital

Yokohama, Japan

Location

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, Malaysia

Location

Academisch Medisch Centrum (AMC)

Amsterdam, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, Netherlands

Location

Klinicki Centar Srbije

Belgrade, Serbia

Location

Groote Schuur Hospital

Cape Town, South Africa

Location

Hospital Universitari Clínic de Barcelona

Barcelona, Spain

Location

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 35025987 DERIVED

• 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.

  PMID: 33428248 DERIVED

• 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.

  PMID: 32763431 DERIVED

• 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.

  PMID: 30168233 DERIVED

• 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.

  PMID: 30103071 DERIVED

• 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.

  PMID: 29476660 DERIVED

• 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.

  PMID: 28566657 DERIVED

• 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.

  PMID: 27871854 DERIVED

• 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.

  PMID: 26551877 DERIVED

• 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.

  PMID: 26045305 DERIVED

• 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.

  PMID: 25855677 DERIVED

Results Point of Contact

• Title: Micra Clinical Team
• Organization: Medtronic Cardiac Rhythm and Heart Failure

MedtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• Dwight Reynolds

  University of Oklahoma

  STUDY CHAIR

• Philippe Ritter

  Hôpital Haut-Lévêque

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2017
• Last Updated: January 17, 2018
• Results First Posted: January 5, 2017

Record last verified: 2017-12

Locations

US (30); IN (3); IT (1); ZA (1); AU (1); FR (1); HU (1); JP (4); CN (1); ES (1); DK (1); GR (1); CZ (1); CA (2); NL (3); SE (1); GB (1); MY (1)