Cardiac ArrhythmiasNCT03505801
Confirm Rx Insertable Cardiac Monitor SMART Registry
An observational study of Cardiac Arrhythmias and Symptoms and Signs, run by Abbott Medical Devices at 113 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation
- What is being tested?
- Confirm Rx ICM insertion procedure
- Type of treatment
- Medical device
- How many people
- 1,826 participants
- Where
- 113 sitesin 24 countries
- Study dates
- 24 Apr 2018to 6 Jan 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
113 sites in 24 countries.
113 sites in 24 countries
Germany16 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin
Klinikum Coburg GmbH
Coburg
Evangelisches Krankenhaus Kalk gGmbH
Cologne
Krankenhaus Porz am Rhein
Cologne
Medizinische Einrichtungen der Universität zu Köln
Cologne
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Klinikum Furth
Fürth
Asklepios Klinik St. Georg
Hamberg, 20099
Klinikum Herford
Herford
Klinikum Idar-Oberstein GmbH
Idar-Oberstein, Hesse
Universitätsklinikum Leipzig AÖR
Leipzig
St.-Marien-Hospital GmbH
Lünen, 44534
München Grosshadern
München
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg
Kliniken Villingen-Schwenningen
Villingen-Schwenningen
United States15 sites
Ascension Texas Cardiovascular
Austin, Texas, 78731
St. Luke's Regional Medical Center
Boise, Idaho, 83712
Bay Area Cardiology Associates PA
Brandon, Florida, 33511
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Kootenai Heart Clinics
Coeur d'Alene, Idaho, 83814
Cardiology Consultants of East Michigan
Flint, Michigan, 48532
Pinnacle Health System
Harrisburg, Pennsylvania, 17105
MedStar Health Research Institute
Hyattsville, Maryland, 20782
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
St. Thomas Hospital
Nashville, Tennessee, 37205
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
Adventist HealthCare White Oak Medical Center
Silver Spring, Maryland, 20904
Bayfront Medical Center
St. Petersburg, Florida, 33701
Iowa Heart Center
West Des Moines, Iowa, 50266
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067
South Korea13 sites
Hallym University Sacred Heart Hospital
Anyang, Gyeongi, 14068
Dong-A University Hospital
Busan, South Gyeongsang Province
Kosin University Gospel Hospital
Busan, Yeongnm
Keimyung University Dongsan Medical Center
Daegu
Inha University Hospital
Junggu, Gyeongi
Seoul National University Bundang Hospital
Seongnam, Sudogwn
Chung Ang University Hospital
Seoul, Sudogwn
Asan Medical Centre
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Ulsan University Hospital
Ulsan, Yeongnm
Italy9 sites
C.D.C. Citta di Aprilia
Aprilia
Az.Osp.Universitaria Consorziale Policlinico
Bari
Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia
Foggia, Apulia
Presidio Ospedaliero Giovan Battista Grassi
Ostia Antica
Casa di Cura Dpott. Pederzoli
Peschiera del Garda
Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna
Ospedale S. Andrea
Roma
Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
Roma
Policlinico Casilino
Roma
Japan9 sites
Saiseikai Fukuoka General Hospital
Fukuoka
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuok, 430-8558
Akashi Medical Center
Hyōgo
St. Marianna University School of Medicine - Toyoko Hospital
Kawasaki
Kokura Memorial Hospital
Kitakyushu
University Hospital of Occupational & Environmental Health
Kitakyushu
Iwate Prefectural Central Hospital
Morioka
Osaka University Hospital
Suita
Yokohamashintoshi Neurosurgical Hospital
Yokohama, Kanagwa
South Africa6 sites
MedClinic Panorama
Cape Town, W Cape, 7500
Groote Schuur Hospital
Cape Town, W Cape, 7935
Unitas Hospital
Centurion
Busamed Hillcrest Private Hospital
Hillcrest
Sunninghill Hospital
Johannesburg, Sandton, 2196
Busamed Gateway Private Hospital
Umhlanga
Canada5 sites
Foothills Medical Centre
Calgary, Alberta
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec
CHUM
Montreal
Institut de Cardiologie de Quebec (Hospital Laval)
Québec
HSC, Eastern Health
St. John's
Netherlands5 sites
Albert Schweitzer Ziekenhuis
Dordrecht
Martini Ziekenhuis
Groningen
Erasmus MC - Thoraxcenter
Rotterdam
Haga Ziekenhuis Locatie Leyenburg
The Hague
Maxima Medisch Centrum
Veldhoven
Portugal5 sites
Hospital Prof. Doutor Fernando Fonseca
Amadora
Hospital de Santa Cruz
Carnaxide
Centro Hospitalar do Alto Ave, Unidade de Guimarães
Creixomil
Hospital de Santo Andre - Centro Hospitalar de Leiria
Leiria
Santa Maria Hospital
Lisbon
Spain5 sites
Hospital Universitario de Badajoz
Badajoz, Extmdra
Hospital de Sant Joan Despí Moisès Broggi
Barcelona
Hospital Puerta de Hierro - Hospital Universitario
Majadahonda
Hospital Universitario Donostia
San Sebastián
Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias
Vigo
Austria3 sites
Kepler Universitätsklinikum GmbH
Linz
Krankenhaus der Stadt St. Pölten
Sankt Pölten
Universitätsklinikum Tulln
Tulln
Belgium3 sites
Hopital Erasme
Brussels
Ziekenhuis Oost-Limburg
Genk
CHU Liège Sart Tilman
Liège
Saudi Arabia3 sites
King Fahad Armed Forces Hospital
Jeddah
King Abdullah Medical City in Holy Capital
Mecca
King Fahad Medical City
Riyadh
United Kingdom3 sites
Royal Bournemouth Hospital
Bournemouth
St Georges Hospital London
London
St. Thomas Hospital
London
Argentina2 sites
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires
Clinica Provincial
Merlo
India2 sites
Advance Medicare Research Institute (AMRI) Hospital
Dhakuria
Max Super Specialty Hospital
New Delhi
Slovakia2 sites
Stredoslovenský ústav srdcových a cievnych chorôb, a.s.
Banská Bystrica, Stredne
The National Institute of Cardiovascular Diseases
Bratislava
About this study
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.
- Conditions
- Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation
- Being tested
- Confirm Rx ICM insertion procedure
- Medical subject headings
- Arrhythmias, Cardiac, Signs and Symptoms, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confirm Rx ICM insertion procedureDevice
Insertion of Confirm Rx ICM device
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device SADEs and serious procedure related SAEs
Measured: 1 month post insertion procedure
Secondary outcomes (2)
Freedom from device SADEs and serious procedure related SAEs
Measured: 12 months post insertion procedure
R wave amplitude
Measured: 12 months post insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start24 Apr 2018
- Primary completion19 Sep 2019
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,826 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabio Quartieri, MD, Principal investigator, Arcispedale S. Maria Nuova - IRCCS l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505801
- Sponsor's protocol ID
- SJM-CIP-10176
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2018
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirm Rx Insertable Cardiac Monitor SMART Registry
- ClinicalTrials.gov ID
- NCT03505801
- Acronym / sponsor ID
- SJM-CIP-10176
- Conditions
- Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,826 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confirm Rx ICM insertion procedureInsertion of Confirm Rx ICM device | Device | – |
Primary outcome
Freedom from device SADEs and serious procedure related SAEs
Time frame: 1 month post insertion procedure
2 secondary outcomes
Freedom from device SADEs and serious procedure related SAEs
Time frame: 12 months post insertion procedure
R wave amplitude
Time frame: 12 months post insertion procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40514061Quartieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Quartieri, MD principal investigator
Arcispedale S. Maria Nuova - IRCCS l
113 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias and Symptoms and Signs, run by Abbott Medical Devices at 113 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in Germany, United States, South Korea, Italy, Japan and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device SADEs and serious procedure related SAEs (time frame: 1 month post insertion procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.