NCT03505801Completed
Confirm Rx Insertable Cardiac Monitor SMART Registry
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1826 (actual)
- First submitted
- 13 Apr 2018
- Start date
- 24 Apr 2018
- Primary completion date
- 19 Sept 2019
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Atrial fibrillation
- NCT number
- NCT03505801
What you commit to
- Study type: Observational
- Participants enrolled: 1826
- From 24 Apr 2018 to the primary completion date, 19 Sept 2019
- 113 sites in 24 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 previous ICM placement.
Other illness
- Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
- Have a life expectancy of less than 1 year due to any condition.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (113)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Argentino de Diagnóstico y Tratamiento Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Clinica Provincial Coordinator of this site? Confirm its status | Merlo | Argentina | Unknown status |
| Kepler Universitatsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Krankenhaus der Stadt St. Pölten Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Unknown status |
| Universitätsklinikum Tulln Coordinator of this site? Confirm its status | Tulln | Austria | Unknown status |
| Hôpital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| CHU Liège- Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Foothills Medical Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Institut de Cardiologie de Montreal (Montreal Heart Inst.) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Institut de Cardiologie de Quebec (Hospital Laval) Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| HSC, Eastern Health Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| Kerckhoff-Klinik gGmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Unknown status |
| Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Klinikum Coburg GmbH Coordinator of this site? Confirm its status | Coburg | Germany | Unknown status |
| Evangelisches Krankenhaus Kalk gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Medizinische Einrichtungen der Universität zu Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Krankenhaus Porz am Rhein Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Herzzentrum Dresden GmbH Universitätsklinik Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Klinikum Fürth Coordinator of this site? Confirm its status | Fürth | Germany | Unknown status |
| Asklepios Klinik St. Georg Coordinator of this site? Confirm its status | Hamberg | Germany | Unknown status |
| Klinikum Herford Coordinator of this site? Confirm its status | Herford | Germany | Unknown status |
| Klinikum Idar-Oberstein GmbH Coordinator of this site? Confirm its status | Idar-Oberstein | Germany | Unknown status |
| Universitätsklinikum Leipzig AöR Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| St.-Marien-Hospital GmbH Coordinator of this site? Confirm its status | Lünen | Germany | Unknown status |
| München Grosshadern Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Harzklinikum Dorothea Christiane Erxleben GmbH Coordinator of this site? Confirm its status | Quedlinburg | Germany | Unknown status |
| Kliniken Villingen-Schwenningen Coordinator of this site? Confirm its status | Villingen-Schwenningen | Germany | Unknown status |
| Hôpital Central de l'Armée Coordinator of this site? Confirm its status | Algiers | Algeria | Unknown status |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Hospital de Sant Joan Despí - Moises Broggi Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Puerta de Hierro - Hospital Universitario Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | San Sebastián | Spain | Unknown status |
| Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Royal Bournemouth Hospital Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Georges Hospital London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Bnai Zion Medical Israel Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Advance Medicare Research Institute (AMRI) Hospital Coordinator of this site? Confirm its status | Dhakuria | India | Unknown status |
| Max Super Specialty Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| C.D.C. Citta di Aprilia Coordinator of this site? Confirm its status | Aprilia | Italy | Unknown status |
| Az.Osp.Universitaria Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Presidio Ospedaliero Giovan Battista Grassi Coordinator of this site? Confirm its status | Ostia Antica | Italy | Unknown status |
| Casa di Cura Dpott. Pederzoli Coordinator of this site? Confirm its status | Peschiera del Garda | Italy | Unknown status |
| Arcispedale Santa Maria Nuova Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Ospedale S. Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Casilino Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale S. Giovanni Calibita Fatebenefratelli di Roma Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Saiseikai Fukuoka General Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Seirei Hamamatsu General Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Unknown status |
| Akashi Medical Center Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| St. Marianna University School of Medicine - Toyoko Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| University Hospital of Occupational & Environmental Health Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Kokura Memorial Hospital Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Iwate Prefectural Central Hospital Coordinator of this site? Confirm its status | Morioka | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Yokohamashintoshi Neurosurgical Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Inha University Hospital Coordinator of this site? Confirm its status | Junggu | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Centre Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Sabah Al-Ahmad Cardiac Centre Coordinator of this site? Confirm its status | Kuwait City | Kuwait | Unknown status |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Unknown status |
| Martini Ziekenhuis Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Erasmus MC - Thoraxcenter Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Haga Ziekenhuis Locatie Leyenburg Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| Maxima Medisch Centrum Coordinator of this site? Confirm its status | Veldhoven | Netherlands | Unknown status |
| Caribbean Heart Institute Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| Hospital Prof. Doutor Fernando Fonseca Coordinator of this site? Confirm its status | Amadora | Portugal | Unknown status |
| Hospital de Santa Cruz Coordinator of this site? Confirm its status | Carnaxide | Portugal | Unknown status |
| Centro Hospitalar do Alto Ave, Unidade de Guimarães Coordinator of this site? Confirm its status | Creixomil | Portugal | Unknown status |
| Hospital de Santo Andre - Centro Hospitalar de Leiria Coordinator of this site? Confirm its status | Leiria | Portugal | Unknown status |
| Santa Maria Hospital Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| King Fahad Armed Forces Hospital Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| King Abdullah Medical City in Holy Capital Coordinator of this site? Confirm its status | Mecca | Saudi Arabia | Unknown status |
| King Fahad Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Changi General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Stredoslovensky ustav srdcovych a cievnych chorob, a.s. Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| The National Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Ascension Texas Cardiovascular Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| St. Luke's Regional Medical Center Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Bay Area Cardiology Associates PA Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Erlanger Medical Center Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Kootenai Heart Clinics Coordinator of this site? Confirm its status | Coeur d'Alene | United States | Unknown status |
| Cardiology Consultants of East Michigan Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Pinnacle Health System Coordinator of this site? Confirm its status | Harrisburg | United States | Unknown status |
| MedStar Health Research Institute Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
| Arrhythmia Research Group Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| St. Thomas Hospital Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Kansas City Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Adventist HealthCare White Oak Medical Center Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Bayfront Medical Center Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Iowa Heart Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Cardiology Consultants of Philadelphia Coordinator of this site? Confirm its status | Yardley | United States | Unknown status |
| Groote Schuur Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| MedClinic Panorama Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Unitas Hospital Coordinator of this site? Confirm its status | Centurion | South Africa | Unknown status |
| Busamed Hillcrest Private Hospital Coordinator of this site? Confirm its status | Hillcrest | South Africa | Unknown status |
| Sunninghill Hospital Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Busamed Gateway Private Hospital Coordinator of this site? Confirm its status | Umhlanga | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.