Confirm Rx Insertable Cardiac Monitor SMART Registry

NCT ID: NCT03505801

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1826 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-24

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Arrhythmias Symptoms and Signs Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Confirm Rx ICM insertion procedure

Insertion of Confirm Rx ICM device

Intervention Type DEVICE

Eligibility Criteria

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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 mobile transmitter that is compatible with the MyMerlin App and able to communicate with the Confirm Rx ICM device.
* Have the ability to provide informed consent for study participation and be willing and 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 to state and national law.

Exclusion Criteria

* Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
* Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study.
* Have a life expectancy of less than 1 year due to any condition.
* Have a previous ICM placement.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Quartieri, MD

Role: PRINCIPAL_INVESTIGATOR

Arcispedale S. Maria Nuova - IRCCS l

Locations

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Arrhythmia Research Group

Jonesboro, Arkansas, United States

Site Status

Bay Area Cardiology Associates PA

Brandon, Florida, United States

Site Status

Bayfront Medical Center

St. Petersburg, Florida, United States

Site Status

St. Luke's Regional Medical Center

Boise, Idaho, United States

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Kootenai Heart Clinics

Coeur d'Alene, Idaho, United States

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Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, United States

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MedStar Health Research Institute

Hyattsville, Maryland, United States

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Adventist HealthCare White Oak Medical Center

Silver Spring, Maryland, United States

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Cardiology Consultants of East Michigan

Flint, Michigan, United States

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Pinnacle Health System

Harrisburg, Pennsylvania, United States

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Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, United States

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Erlanger Medical Center

Chattanooga, Tennessee, United States

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St. Thomas Hospital

Nashville, Tennessee, United States

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Ascension Texas Cardiovascular

Austin, Texas, United States

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Hôpital Central de l'Armée

Algiers, , Algeria

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Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, , Argentina

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Clinica Provincial

Merlo, , Argentina

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Kepler Universitätsklinikum GmbH

Linz, , Austria

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Krankenhaus der Stadt St. Pölten

Sankt Pölten, , Austria

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Universitätsklinikum Tulln

Tulln, , Austria

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Hopital Erasme

Brussels, , Belgium

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Ziekenhuis Oost-Limburg

Genk, , Belgium

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CHU Liège Sart Tilman

Liège, , Belgium

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Foothills Medical Centre

Calgary, Alberta, Canada

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Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

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Institut de Cardiologie de Quebec (Hospital Laval)

Québec, Quebec, Canada

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CHUM

Montreal, , Canada

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HSC, Eastern Health

St. John's, , Canada

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Asklepios Klinik St. Georg

Hamberg, Hamberg, Germany

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Klinikum Idar-Oberstein GmbH

Idar-Oberstein, Hesse, Germany

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Kerckhoff-Klinik gGmbH

Bad Nauheim, , Germany

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Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, , Germany

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Klinikum Coburg GmbH

Coburg, , Germany

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Evangelisches Krankenhaus Kalk gGmbH

Cologne, , Germany

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Krankenhaus Porz am Rhein

Cologne, , Germany

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Medizinische Einrichtungen der Universität zu Köln

Cologne, , Germany

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Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

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Klinikum Furth

Fürth, , Germany

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Klinikum Herford

Herford, , Germany

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Universitätsklinikum Leipzig AÖR

Leipzig, , Germany

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St.-Marien-Hospital GmbH

Lünen, , Germany

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München Grosshadern

München, , Germany

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Harzklinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, , Germany

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Kliniken Villingen-Schwenningen

Villingen-Schwenningen, , Germany

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Semmelweis University

Budapest, Budapst, Hungary

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Advance Medicare Research Institute (AMRI) Hospital

Dhakuria, , India

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Max Super Specialty Hospital

New Delhi, , India

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Bnai Zion Medical Israel

Haifa, Haifa District, Israel

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Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia

Foggia, Apulia, Italy

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Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, Italy

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C.D.C. Citta di Aprilia

Aprilia, , Italy

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Az.Osp.Universitaria Consorziale Policlinico

Bari, , Italy

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Presidio Ospedaliero Giovan Battista Grassi

Ostia Antica, , Italy

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Casa di Cura Dpott. Pederzoli

Peschiera del Garda, , Italy

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Ospedale S. Andrea

Roma, , Italy

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Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

Roma, , Italy

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Policlinico Casilino

Roma, , Italy

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Yokohamashintoshi Neurosurgical Hospital

Yokohama, Kanagwa, Japan

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Seirei Hamamatsu General Hospital

Hamamatsu, Shizuok, Japan

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Saiseikai Fukuoka General Hospital

Fukuoka, , Japan

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Akashi Medical Center

Hyōgo, , Japan

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St. Marianna University School of Medicine - Toyoko Hospital

Kawasaki, , Japan

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Kokura Memorial Hospital

Kitakyushu, , Japan

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University Hospital of Occupational & Environmental Health

Kitakyushu, , Japan

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Iwate Prefectural Central Hospital

Morioka, , Japan

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Osaka University Hospital

Suita, , Japan

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Sabah Al-Ahmad Cardiac Centre

Kuwait City, , Kuwait

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Pauls Stradins Clinical University Hospital

Riga, , Latvia

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Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

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Martini Ziekenhuis

Groningen, , Netherlands

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Erasmus MC - Thoraxcenter

Rotterdam, , Netherlands

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Haga Ziekenhuis Locatie Leyenburg

The Hague, , Netherlands

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Maxima Medisch Centrum

Veldhoven, , Netherlands

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Hospital Prof. Doutor Fernando Fonseca

Amadora, , Portugal

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Hospital de Santa Cruz

Carnaxide, , Portugal

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Centro Hospitalar do Alto Ave, Unidade de Guimarães

Creixomil, , Portugal

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Hospital de Santo Andre - Centro Hospitalar de Leiria

Leiria, , Portugal

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Santa Maria Hospital

Lisbon, , Portugal

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Caribbean Heart Institute

Caguas, , Puerto Rico

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King Fahad Armed Forces Hospital

Jeddah, , Saudi Arabia

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King Abdullah Medical City in Holy Capital

Mecca, , Saudi Arabia

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King Fahad Medical City

Riyadh, , Saudi Arabia

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Changi General Hospital

Singapore, Singapore, Singapore

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Stredoslovenský ústav srdcových a cievnych chorôb, a.s.

Banská Bystrica, Stredne, Slovakia

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The National Institute of Cardiovascular Diseases

Bratislava, , Slovakia

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Sunninghill Hospital

Johannesburg, Sandton, South Africa

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MedClinic Panorama

Cape Town, W Cape, South Africa

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Groote Schuur Hospital

Cape Town, W Cape, South Africa

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Unitas Hospital

Centurion, , South Africa

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Busamed Hillcrest Private Hospital

Hillcrest, , South Africa

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Busamed Gateway Private Hospital

Umhlanga, , South Africa

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Hallym University Sacred Heart Hospital

Anyang, Gyeongi, South Korea

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Inha University Hospital

Junggu, Gyeongi, South Korea

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Dong-A University Hospital

Busan, South Gyeongsang Province, South Korea

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Seoul National University Bundang Hospital

Seongnam, Sudogwn, South Korea

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Chung Ang University Hospital

Seoul, Sudogwn, South Korea

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Kosin University Gospel Hospital

Busan, Yeongnm, South Korea

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Ulsan University Hospital

Ulsan, Yeongnm, South Korea

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Keimyung University Dongsan Medical Center

Daegu, , South Korea

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Asan Medical Centre

Seoul, , South Korea

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Korea University Anam Hospital

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Seoul National University Hospital

Seoul, , South Korea

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

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Hospital Universitario de Badajoz

Badajoz, Extmdra, Spain

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Hospital de Sant Joan Despí Moisès Broggi

Barcelona, , Spain

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Hospital Puerta de Hierro - Hospital Universitario

Majadahonda, , Spain

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Hospital Universitario Donostia

San Sebastián, , Spain

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Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias

Vigo, , Spain

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St. Thomas Hospital

London, London, United Kingdom

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Royal Bournemouth Hospital

Bournemouth, , United Kingdom

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St Georges Hospital London

London, , United Kingdom

Site Status

Countries

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United States Algeria Argentina Austria Belgium Canada Germany Hungary India Israel Italy Japan Kuwait Latvia Netherlands Portugal Puerto Rico Saudi Arabia Singapore Slovakia South Africa South Korea Spain United Kingdom

References

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Quartieri F, Baek YS, Park JS, Kim TH, Honma K, Morimoto M, Kang KW, Feng L, Lee K, Grammatico A, Kaiser L. Continuing evaluation of atrial fibrillation detection after cryptogenic stroke: 2-year findings from a multicentre study with Confirm Rx ICM. Open Heart. 2025 Jun 12;12(1):e003242. doi: 10.1136/openhrt-2025-003242.

Reference Type DERIVED
PMID: 40514061 (View on PubMed)

Other Identifiers

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SJM-CIP-10176

Identifier Type: -

Identifier Source: org_study_id