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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Universitatsklinikum GmbH
      • Sankt Pölten, Austria
        • Krankenhaus der Stadt St. Pölten
      • Tulln, Austria
        • Universitätsklinikum Tulln
  • Belgium
      • Brussels, Belgium
        • Hopital 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 Stradins 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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