Confirm Rx Insertable Cardiac Monitor SMART Registry

Last updated: November 5, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Circulation Disorders

Arrhythmia

Treatment

Confirm Rx ICM insertion procedure

Clinical Study ID

NCT03505801
SJM-CIP-10176
  • Ages > 18
  • All Genders

Study Summary

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have an approved indication for continuous arrhythmia monitoring with an ICM

  • Have a cellular phone or the ability or willing to use a St. Jude Medical mobiletransmitter that is compatible with the MyMerlin App and able to communicate withthe Confirm Rx ICM device.

  • Have the ability to provide informed consent for study participation and be willingand able to comply with the prescribed follow-up tests and schedule of evaluations.

  • Are 18 years of age or older, or of legal age to give informed consent specific tostate and national law.

Exclusion

Exclusion Criteria:

  • Subject is implanted with or indicated for implant with a pacemaker, implantablecardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.

  • Enrolled or intend to participate in a clinical drug and/or device study, whichcould confound the results of this trial as determined by the sponsor, during thecourse of this clinical study.

  • Have a life expectancy of less than 1 year due to any condition.

  • Have a previous ICM placement.

Study Design

Total Participants: 1826
Treatment Group(s): 1
Primary Treatment: Confirm Rx ICM insertion procedure
Phase:
Study Start date:
April 24, 2018
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Hôpital Central de l'Armée

    Algier,
    Algeria

    Site Not Available

  • Instituto Argentino de Diagnostico y Tratamiento

    Buenos Aires,
    Argentina

    Site Not Available

  • Clinica Provincial

    Merlo,
    Argentina

    Site Not Available

  • Kepler Universitätsklinikum GmbH

    Linz,
    Austria

    Site Not Available

  • Krankenhaus der Stadt St. Pölten

    Sankt Pölten,
    Austria

    Site Not Available

  • Universitätsklinikum Tulln

    Tulln,
    Austria

    Site Not Available

  • UZ Brussel

    Brussel,
    Belgium

    Site Not Available

  • Hopital Erasme

    Brussels,
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg

    Genk,
    Belgium

    Site Not Available

  • CHU Liège Sart Tilman

    Liège,
    Belgium

    Site Not Available

  • Foothills Medical Centre

    Calgary, Alberta
    Canada

    Site Not Available

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec
    Canada

    Site Not Available

  • CHUM

    Montréal,
    Canada

    Site Not Available

  • Institut de Cardiologie de Quebec (Hospital Laval)

    Quebec,
    Canada

    Site Not Available

  • HSC, Eastern Health

    Saint John's,
    Canada

    Site Not Available

  • Klinikum Idar-Oberstein GmbH

    Idar-Oberstein, Hesse
    Germany

    Site Not Available

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim,
    Germany

    Site Not Available

  • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin,
    Germany

    Site Not Available

  • Klinikum Coburg GmbH

    Coburg,
    Germany

    Site Not Available

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden,
    Germany

    Site Not Available

  • Klinikum Furth

    Fürth,
    Germany

    Site Not Available

  • Asklepios Klinik St. Georg

    Hamberg, 20099
    Germany

    Site Not Available

  • Klinikum Herford

    Herford,
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Kalk gGmbH

    Köln,
    Germany

    Site Not Available

  • Krankenhaus Porz am Rhein

    Köln,
    Germany

    Site Not Available

  • Medizinische Einrichtungen der Universität zu Köln

    Köln,
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig AÖR

    Leipzig,
    Germany

    Site Not Available

  • St.-Marien-Hospital GmbH

    Lünen, 44534
    Germany

    Site Not Available

  • München Grosshadern

    München,
    Germany

    Site Not Available

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg,
    Germany

    Site Not Available

  • Kliniken Villingen-Schwenningen

    Villingen-Schwenningen,
    Germany

    Site Not Available

  • Semmelweis University

    Budapest, Budapst
    Hungary

    Site Not Available

  • Advance Medicare Research Institute (AMRI) Hospital

    Dhakuria,
    India

    Site Not Available

  • Max Super Specialty Hospital

    New Delhi,
    India

    Site Not Available

  • Bnai Zion Medical Israel

    Haifa,
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia

    Foggia, Apulia
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna
    Italy

    Site Not Available

  • C.D.C. Citta di Aprilia

    Aprilia,
    Italy

    Site Not Available

  • Az.Osp.Universitaria Consorziale Policlinico

    Bari,
    Italy

    Site Not Available

  • Presidio Ospedaliero Giovan Battista Grassi

    Ostia,
    Italy

    Site Not Available

  • Casa di Cura Dpott. Pederzoli

    Peschiera Del Garda,
    Italy

    Site Not Available

  • Ospedale S. Andrea

    Roma,
    Italy

    Site Not Available

  • Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

    Roma,
    Italy

    Site Not Available

  • Policlinico Casilino

    Roma,
    Italy

    Site Not Available

  • Yokohamashintoshi Neurosurgical Hospital

    Yokohama, Kanagwa
    Japan

    Site Not Available

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuok 430-8558
    Japan

    Site Not Available

  • Saiseikai Fukuoka General Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Akashi Medical Center

    Hyōgo,
    Japan

    Site Not Available

  • St. Marianna University School of Medicine - Toyoko Hospital

    Kawasaki,
    Japan

    Site Not Available

  • Kokura Memorial Hospital

    Kitakyushu,
    Japan

    Site Not Available

  • University Hospital of Occupational & Environmental Health

    Kitakyushu,
    Japan

    Site Not Available

  • Iwate Prefectural Central Hospital

    Morioka,
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita,
    Japan

    Site Not Available

  • Hallym University Sacred Heart Hospital

    Anyang, Gyeongi 14068
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Junggu, Gyeongi
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Busan, South Gyeongsang Province
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Sudogwn
    Korea, Republic of

    Site Not Available

  • Chung Ang University Hospital

    Seoul, Sudogwn
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, Yeongnm
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan-si, Yeongnm
    Korea, Republic of

    Site Not Available

  • Sejong Hospital

    Bucheon,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Asan Medical Centre

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

  • Sabah Al-Ahmad Cardiac Centre

    Kuwait,
    Kuwait

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Site Not Available

  • Haga Ziekenhuis Locatie Leyenburg

    Den Haag,
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht,
    Netherlands

    Site Not Available

  • Martini Ziekenhuis

    Groningen,
    Netherlands

    Site Not Available

  • Erasmus MC - Thoraxcenter

    Rotterdam,
    Netherlands

    Site Not Available

  • Maxima Medisch Centrum

    Veldhoven,
    Netherlands

    Site Not Available

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora,
    Portugal

    Site Not Available

  • Hospital de Santa Cruz

    Carnaxide,
    Portugal

    Site Not Available

  • Centro Hospitalar do Alto Ave, Unidade de Guimarães

    Creixomil,
    Portugal

    Site Not Available

  • Hospital de Santo Andre - Centro Hospitalar de Leiria

    Leiria,
    Portugal

    Site Not Available

  • Santa Maria Hospital

    Lisboa,
    Portugal

    Site Not Available

  • Caribbean Heart Institute

    Caguas, 00727
    Puerto Rico

    Site Not Available

  • King Fahad Armed Forces Hospital

    Jeddah,
    Saudi Arabia

    Site Not Available

  • King Abdullah Medical City in Holy Capital

    Mecca,
    Saudi Arabia

    Site Not Available

  • King Fahad Medical City

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Stredoslovenský ústav srdcových a cievnych chorôb, a.s.

    Banská Bystrica, Stredne
    Slovakia

    Site Not Available

  • The National Institute of Cardiovascular Diseases

    Bratislava,
    Slovakia

    Site Not Available

  • Sunninghill Hospital

    Johannesburg, Sandton 2196
    South Africa

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, W Cape 7935
    South Africa

    Site Not Available

  • MedClinic Panorama

    Cape Town, W Cape 7500
    South Africa

    Site Not Available

  • Unitas Hospital

    Centurion,
    South Africa

    Site Not Available

  • Busamed Hillcrest Private Hospital

    Hillcrest,
    South Africa

    Site Not Available

  • Busamed Gateway Private Hospital

    Umhlanga,
    South Africa

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz, Extmdra
    Spain

    Site Not Available

  • Hospital Universitario Infanta Cristina

    Badajoz,
    Spain

    Site Not Available

  • Hospital de Sant Joan Despí Moisès Broggi

    Barcelona,
    Spain

    Site Not Available

  • Hospital Puerta de Hierro - Hospital Universitario

    Majadahonda,
    Spain

    Site Not Available

  • Hospital Universitario Donostia

    San Sebastián,
    Spain

    Site Not Available

  • Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias

    Vigo,
    Spain

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth,
    United Kingdom

    Site Not Available

  • St Georges Hospital London

    London,
    United Kingdom

    Site Not Available

  • St. Thomas Hospital

    London,
    United Kingdom

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Bay Area Cardiology Associates PA

    Brandon, Florida 33511
    United States

    Site Not Available

  • Bayfront Medical Center

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Boise, Idaho 83712
    United States

    Site Not Available

  • Kootenai Heart Clinics

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • MedStar Health Research Institute

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Adventist HealthCare White Oak Medical Center

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Cardiology Consultants of East Michigan

    Flint, Michigan 48532
    United States

    Site Not Available

  • Pinnacle Health System

    Harrisburg, Pennsylvania 17105
    United States

    Site Not Available

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania 19067
    United States

    Site Not Available

  • Erlanger Medical Center

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • St. Thomas Hospital

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Ascension Texas Cardiovascular

    Austin, Texas 78731
    United States

    Site Not Available

  • Seton Medical Center

    Austin, Texas 78705
    United States

    Site Not Available

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