CClinicalTrials.gg
CompletedNCT03505801Updated May 6, 2026

Confirm Rx Insertable Cardiac Monitor SMART Registry

An observational study in Cardiac Arrhythmias, Symptoms and Signs and Atrial Fibrillation, sponsored by Abbott Medical Devices. Completed at 113 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,826
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Cardiac Arrhythmias
  • Symptoms and Signs
  • Atrial Fibrillation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,826 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceConfirm Rx ICM insertion procedure

    Insertion of Confirm Rx ICM device

05

What researchers measure

Primary outcomes

  1. Freedom from device SADEs and serious procedure related SAEs

    Time frame: 1 month post insertion procedure

Secondary outcomes

  1. Freedom from device SADEs and serious procedure related SAEs

    Time frame: 12 months post insertion procedure

  2. R wave amplitude

    Time frame: 12 months post insertion procedure

06

Study locations

113 sites
  • Arrhythmia Research Group
    Jonesboro, Arkansas 72401, United States
  • Bay Area Cardiology Associates PA
    Brandon, Florida 33511, United States
  • Bayfront Medical Center
    St. Petersburg, Florida 33701, United States
  • St. Luke's Regional Medical Center
    Boise, Idaho 83712, United States
  • Kootenai Heart Clinics
    Coeur d'Alene, Idaho 83814, United States
  • Iowa Heart Center
    West Des Moines, Iowa 50266, United States
  • Kansas City Cardiac Arrhythmia Research Foundation
    Overland Park, Kansas 66211, United States
  • MedStar Health Research Institute
    Hyattsville, Maryland 20782, United States
  • Adventist HealthCare White Oak Medical Center
    Silver Spring, Maryland 20904, United States
  • Cardiology Consultants of East Michigan
    Flint, Michigan 48532, United States
  • Pinnacle Health System
    Harrisburg, Pennsylvania 17105, United States
  • Cardiology Consultants of Philadelphia
    Yardley, Pennsylvania 19067, United States
  • Erlanger Medical Center
    Chattanooga, Tennessee 37403, United States
  • St. Thomas Hospital
    Nashville, Tennessee 37205, United States
  • Ascension Texas Cardiovascular
    Austin, Texas 78731, 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
  • CHUM
    Montreal, Canada
  • Institut de Cardiologie de Quebec (Hospital Laval)
    Québec, Canada
  • HSC, Eastern Health
    St. John's, Canada
  • 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
  • Asklepios Klinik St. Georg
    Hamberg, 20099, Germany
  • Klinikum Herford
    Herford, Germany
  • Universitätsklinikum Leipzig AÖR
    Leipzig, Germany
  • St.-Marien-Hospital GmbH
    Lünen, 44534, 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, 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 430-8558, 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, 00727, 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, 529889, 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 2196, South Africa
  • MedClinic Panorama
    Cape Town, W Cape 7500, South Africa
  • Groote Schuur Hospital
    Cape Town, W Cape 7935, 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 14068, 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

Showing the first 100 of 113 sites across 24 countries.

07

References and documents

Publications

  • 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. PubMed 40514061 ↗
08

Registry details

Key details

Study ID
NCT03505801
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Apr 23, 2018
Start date
Apr 24, 2018
Primary completion
Sep 19, 2019
Completion
Jan 6, 2026
Last update
May 6, 2026

Study contacts

Fabio Quartieri, MD
principal investigator · Arcispedale S. Maria Nuova - IRCCS l

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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