Confirm Rx Insertable Cardiac Monitor SMART Registry

April 30, 2026 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1826

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria
        • Hôpital Central de l'Armée
  • Argentina
      • Buenos Aires, Argentina
        • Instituto Argentino de Diagnóstico y Tratamiento
      • Merlo, Argentina
        • Clinica Provincial
  • Austria
      • Linz, Austria
        • Kepler Universitätsklinikum GmbH
      • Sankt Pölten, Austria
        • Krankenhaus der Stadt St. Pölten
      • Tulln, Austria
        • Universitätsklinikum Tulln
  • Belgium
      • Brussels, Belgium
        • Hôpital Erasme
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Liège, Belgium
        • CHU Liège Sart Tilman
  • Canada
      • Montreal, Canada
        • CHUM
      • Québec, Canada
        • Institut de Cardiologie de Quebec (Hospital Laval)
      • St. John's, Canada
        • HSC, Eastern Health
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik gGmbH
      • Berlin, Germany
        • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
      • Coburg, Germany
        • Klinikum Coburg GmbH
      • Cologne, Germany
        • Evangelisches Krankenhaus Kalk gGmbH
      • Cologne, Germany
        • Krankenhaus Porz am Rhein
      • Cologne, Germany
        • Medizinische Einrichtungen der Universität zu Köln
      • Dresden, Germany
        • Herzzentrum Dresden GmbH Universitätsklinik
      • Fürth, Germany
        • Klinikum Fürth
      • Hamberg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Herford, Germany
        • Klinikum Herford
      • Leipzig, Germany
        • Universitätsklinikum Leipzig AöR
      • Lünen, Germany, 44534
        • St.-Marien-Hospital GmbH
      • München, Germany
        • München Grosshadern
      • Quedlinburg, Germany
        • Harzklinikum Dorothea Christiane Erxleben GmbH
      • Villingen-Schwenningen, Germany
        • Kliniken Villingen-Schwenningen
    • Hesse
      • Idar-Oberstein, Hesse, Germany
        • Klinikum Idar-Oberstein GmbH
  • Hungary
    • Budapst
      • Budapest, Budapst, Hungary
        • Semmelweis University
  • India
      • Dhakuria, India
        • Advance Medicare Research Institute (AMRI) Hospital
      • New Delhi, India
        • Max Super Specialty Hospital
  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Israel
  • Italy
      • Aprilia, Italy
        • C.D.C. Citta di Aprilia
      • Bari, Italy
        • Az.Osp.Universitaria Consorziale Policlinico
      • Ostia Antica, Italy
        • Presidio Ospedaliero Giovan Battista Grassi
      • Peschiera del Garda, Italy
        • Casa di Cura Dpott. Pederzoli
      • Roma, Italy
        • Policlinico Casilino
      • Roma, Italy
        • Ospedale S. Andrea
      • Roma, Italy
        • Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
    • Apulia
      • Foggia, Apulia, Italy
        • Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy
        • Arcispedale Santa Maria Nuova
  • Japan
      • Fukuoka, Japan
        • Saiseikai Fukuoka General Hospital
      • Hyōgo, Japan
        • Akashi Medical Center
      • Kawasaki, Japan
        • St. Marianna University School of Medicine - Toyoko Hospital
      • Kitakyushu, Japan
        • Kokura Memorial Hospital
      • Kitakyushu, Japan
        • University Hospital of Occupational & Environmental Health
      • Morioka, Japan
        • Iwate Prefectural Central Hospital
      • Suita, Japan
        • Osaka University Hospital
    • Kanagwa
      • Yokohama, Kanagwa, Japan
        • Yokohamashintoshi Neurosurgical Hospital
    • Shizuok
      • Hamamatsu, Shizuok, Japan, 430-8558
        • Seirei Hamamatsu General Hospital
  • Kuwait
      • Kuwait City, Kuwait
        • Sabah Al-Ahmad Cardiac Centre
  • Latvia
      • Riga, Latvia
        • Pauls Stradinš Clinical University Hospital
  • Netherlands
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus MC - Thoraxcenter
      • The Hague, Netherlands
        • Haga Ziekenhuis Locatie Leyenburg
      • Veldhoven, Netherlands
        • Maxima Medisch Centrum
  • Portugal
      • Amadora, Portugal
        • Hospital Prof. Doutor Fernando Fonseca
      • Carnaxide, Portugal
        • Hospital de Santa Cruz
      • Creixomil, Portugal
        • Centro Hospitalar do Alto Ave, Unidade de Guimarães
      • Leiria, Portugal
        • Hospital de Santo Andre - Centro Hospitalar de Leiria
      • Lisbon, Portugal
        • Santa Maria Hospital
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Caribbean Heart Institute
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Fahad Armed Forces Hospital
      • Mecca, Saudi Arabia
        • King Abdullah Medical City in Holy Capital
      • Riyadh, Saudi Arabia
        • King Fahad Medical City
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital
  • Slovakia
      • Bratislava, Slovakia
        • The National Institute of Cardiovascular Diseases
    • Stredne
      • Banská Bystrica, Stredne, Slovakia
        • Stredoslovenský ústav srdcových a cievnych chorôb, a.s.
  • South Africa
      • Centurion, South Africa
        • Unitas Hospital
      • Hillcrest, South Africa
        • Busamed Hillcrest Private Hospital
      • Umhlanga, South Africa
        • Busamed Gateway Private Hospital
    • Sandton
      • Johannesburg, Sandton, South Africa, 2196
        • Sunninghill Hospital
    • W Cape
      • Cape Town, W Cape, South Africa, 7500
        • MedClinic Panorama
      • Cape Town, W Cape, South Africa, 7935
        • Groote Schuur Hospital
  • South Korea
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • 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
        • Asan Medical Centre
    • Gyeongi
      • Anyang, Gyeongi, South Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Junggu, Gyeongi, South Korea
        • Inha University Hospital
    • South Gyeongsang Province
      • Busan, South Gyeongsang Province, South Korea
        • Dong-A University Hospital
    • Sudogwn
      • Seongnam, Sudogwn, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, Sudogwn, South Korea
        • Chung Ang University Hospital
    • Yeongnm
      • Busan, Yeongnm, South Korea
        • Kosin University Gospel Hospital
      • Ulsan, Yeongnm, South Korea
        • Ulsan University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital de Sant Joan Despi Moises Broggi
      • Majadahonda, Spain
        • Hospital Puerta de Hierro - Hospital Universitario
      • San Sebastián, Spain
        • Hospital Universitario Donostia
      • Vigo, Spain
        • Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias
    • Extmdra
      • Badajoz, Extmdra, Spain
        • Hospital Universitario de Badajoz
  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • London, United Kingdom
        • St. Thomas Hospital
      • London, United Kingdom
        • St Georges Hospital London
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Cardiology Associates PA
      • St. Petersburg, Florida, United States, 33701
        • Bayfront Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Regional Medical Center
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Heart Clinics
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Cardiac Arrhythmia Research Foundation
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Medstar Health Research Institute
      • Silver Spring, Maryland, United States, 20904
        • Adventist Healthcare White Oak Medical Center
    • Michigan
      • Flint, Michigan, United States, 48532
        • Cardiology Consultants of East Michigan
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17105
        • Pinnacle Health System
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Hospital
    • Texas
      • Austin, Texas, United States, 78731
        • Ascension Texas Cardiovascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects over the age of 18 years (or of legal age specific to state and national law) who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as subjects who are at risk for cardiac arrhythmias, have been previously diagnosed with atrial fibrillation, or who are susceptible to developing atrial fibrillation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from device SADEs and serious procedure related SAEs
Time Frame: 1 month post insertion procedure
1 month post insertion procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from device SADEs and serious procedure related SAEs
Time Frame: 12 months post insertion procedure
12 months post insertion procedure
R wave amplitude
Time Frame: 12 months post insertion procedure
12 months post insertion procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Fabio Quartieri, MD, Arcispedale S. Maria Nuova - IRCCS l

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

September 19, 2019

Study Completion (Actual)

January 6, 2026

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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