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ACTIVE NOT RECRUITING
NCT03505801

Confirm Rx Insertable Cardiac Monitor SMART Registry

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1826

Start Date

2018-04-24

Completion Date

2026-03-31

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DEVICE

Confirm Rx ICM insertion procedure

Insertion of Confirm Rx ICM device

Locations (113)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Bay Area Cardiology Associates PA

Brandon, Florida, United States

Bayfront Medical Center

St. Petersburg, Florida, United States

St. Luke's Regional Medical Center

Boise, Idaho, United States

Kootenai Heart Clinics

Coeur d'Alene, Idaho, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, United States

MedStar Health Research Institute

Hyattsville, Maryland, United States

Adventist HealthCare White Oak Medical Center

Silver Spring, Maryland, United States

Cardiology Consultants of East Michigan

Flint, Michigan, United States

Pinnacle Health System

Harrisburg, Pennsylvania, United States

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

St. Thomas Hospital

Nashville, Tennessee, United States

Ascension Texas Cardiovascular

Austin, Texas, United States

Hôpital Central de l'Armée

Algiers, Algeria

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

Clinica Provincial

Merlo, Argentina

Kepler Universitätsklinikum GmbH

Linz, Austria

Krankenhaus der Stadt St. Pölten

Sankt Pölten, Austria

Universitätsklinikum Tulln

Tulln, Austria

Hopital Erasme

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

CHU Liège Sart Tilman

Liège, Belgium

Foothills Medical Centre

Calgary, Alberta, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Institut de Cardiologie de Quebec (Hospital Laval)

Québec, Quebec, Canada

CHUM

Montreal, Canada

HSC, Eastern Health

St. John's, Canada

Asklepios Klinik St. Georg

Hamberg, Hamberg, Germany

Klinikum Idar-Oberstein GmbH

Idar-Oberstein, Hesse, Germany

Kerckhoff-Klinik gGmbH

Bad Nauheim, Germany

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Germany

Klinikum Coburg GmbH

Coburg, Germany

Evangelisches Krankenhaus Kalk gGmbH

Cologne, Germany

Krankenhaus Porz am Rhein

Cologne, Germany

Medizinische Einrichtungen der Universität zu Köln

Cologne, Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Germany

Klinikum Furth

Fürth, Germany

Klinikum Herford

Herford, Germany

Universitätsklinikum Leipzig AÖR

Leipzig, Germany

St.-Marien-Hospital GmbH

Lünen, Germany

München Grosshadern

München, Germany

Harzklinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, Germany

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, Germany

Semmelweis University

Budapest, Budapst, Hungary

Advance Medicare Research Institute (AMRI) Hospital

Dhakuria, India

Max Super Specialty Hospital

New Delhi, India

Bnai Zion Medical Israel

Haifa, Haifa District, Israel

Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia

Foggia, Apulia, Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, Italy

C.D.C. Citta di Aprilia

Aprilia, Italy

Az.Osp.Universitaria Consorziale Policlinico

Bari, Italy

Presidio Ospedaliero Giovan Battista Grassi

Ostia Antica, Italy

Casa di Cura Dpott. Pederzoli

Peschiera del Garda, Italy

Ospedale S. Andrea

Roma, Italy

Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

Roma, Italy

Policlinico Casilino

Roma, Italy

Yokohamashintoshi Neurosurgical Hospital

Yokohama, Kanagwa, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuok, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, Japan

Akashi Medical Center

Hyōgo, Japan

St. Marianna University School of Medicine - Toyoko Hospital

Kawasaki, Japan

Kokura Memorial Hospital

Kitakyushu, Japan

University Hospital of Occupational & Environmental Health

Kitakyushu, Japan

Iwate Prefectural Central Hospital

Morioka, Japan

Osaka University Hospital

Suita, Japan

Sabah Al-Ahmad Cardiac Centre

Kuwait City, Kuwait

Pauls Stradins Clinical University Hospital

Riga, Latvia

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Erasmus MC - Thoraxcenter

Rotterdam, Netherlands

Haga Ziekenhuis Locatie Leyenburg

The Hague, Netherlands

Maxima Medisch Centrum

Veldhoven, Netherlands

Hospital Prof. Doutor Fernando Fonseca

Amadora, Portugal

Hospital de Santa Cruz

Carnaxide, Portugal

Centro Hospitalar do Alto Ave, Unidade de Guimarães

Creixomil, Portugal

Hospital de Santo Andre - Centro Hospitalar de Leiria

Leiria, Portugal

Santa Maria Hospital

Lisbon, Portugal

Caribbean Heart Institute

Caguas, Puerto Rico

King Fahad Armed Forces Hospital

Jeddah, Saudi Arabia

King Abdullah Medical City in Holy Capital

Mecca, Saudi Arabia

King Fahad Medical City

Riyadh, Saudi Arabia

Changi General Hospital

Singapore, Singapore, Singapore

Stredoslovenský ústav srdcových a cievnych chorôb, a.s.

Banská Bystrica, Stredne, Slovakia

The National Institute of Cardiovascular Diseases

Bratislava, Slovakia

Sunninghill Hospital

Johannesburg, Sandton, South Africa

MedClinic Panorama

Cape Town, W Cape, South Africa

Groote Schuur Hospital

Cape Town, W Cape, South Africa

Unitas Hospital

Centurion, South Africa

Busamed Hillcrest Private Hospital

Hillcrest, South Africa

Busamed Gateway Private Hospital

Umhlanga, South Africa

Hallym University Sacred Heart Hospital

Anyang, Gyeongi, South Korea

Inha University Hospital

Junggu, Gyeongi, South Korea

Dong-A University Hospital

Busan, South Gyeongsang Province, South Korea

Seoul National University Bundang Hospital

Seongnam, Sudogwn, South Korea

Chung Ang University Hospital

Seoul, Sudogwn, South Korea

Kosin University Gospel Hospital

Busan, Yeongnm, South Korea

Ulsan University Hospital

Ulsan, Yeongnm, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Asan Medical Centre

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Universitario de Badajoz

Badajoz, Extmdra, Spain

Hospital de Sant Joan Despí Moisès Broggi

Barcelona, Spain

Hospital Puerta de Hierro - Hospital Universitario

Majadahonda, Spain

Hospital Universitario Donostia

San Sebastián, Spain

Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias

Vigo, Spain

St. Thomas Hospital

London, London, United Kingdom

Royal Bournemouth Hospital

Bournemouth, United Kingdom

St Georges Hospital London

London, United Kingdom