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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
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

Full criteria on ClinicalTrials.gov

Sites (113)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Argentino de Diagnóstico y Tratamiento
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Buenos AiresArgentinaUnknown status
Clinica Provincial
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MerloArgentinaUnknown status
Kepler Universitatsklinikum GmbH
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LinzAustriaUnknown status
Krankenhaus der Stadt St. Pölten
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Sankt PöltenAustriaUnknown status
Universitätsklinikum Tulln
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TullnAustriaUnknown status
Hôpital Erasme
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BrusselsBelgiumUnknown status
Ziekenhuis Oost-Limburg
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GenkBelgiumUnknown status
CHU Liège- Sart Tilman
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LiègeBelgiumUnknown status
Foothills Medical Centre
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CalgaryCanadaUnknown status
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
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MontrealCanadaUnknown status
CHUM
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MontrealCanadaUnknown status
Institut de Cardiologie de Quebec (Hospital Laval)
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QuébecCanadaUnknown status
HSC, Eastern Health
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St. John'sCanadaUnknown status
Kerckhoff-Klinik gGmbH
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Bad NauheimGermanyUnknown status
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
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BerlinGermanyUnknown status
Klinikum Coburg GmbH
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CoburgGermanyUnknown status
Evangelisches Krankenhaus Kalk gGmbH
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CologneGermanyUnknown status
Medizinische Einrichtungen der Universität zu Köln
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CologneGermanyUnknown status
Krankenhaus Porz am Rhein
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CologneGermanyUnknown status
Herzzentrum Dresden GmbH Universitätsklinik
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DresdenGermanyUnknown status
Klinikum Fürth
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FürthGermanyUnknown status
Asklepios Klinik St. Georg
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HambergGermanyUnknown status
Klinikum Herford
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HerfordGermanyUnknown status
Klinikum Idar-Oberstein GmbH
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Idar-ObersteinGermanyUnknown status
Universitätsklinikum Leipzig AöR
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LeipzigGermanyUnknown status
St.-Marien-Hospital GmbH
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LünenGermanyUnknown status
München Grosshadern
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MünchenGermanyUnknown status
Harzklinikum Dorothea Christiane Erxleben GmbH
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QuedlinburgGermanyUnknown status
Kliniken Villingen-Schwenningen
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Villingen-SchwenningenGermanyUnknown status
Hôpital Central de l'Armée
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AlgiersAlgeriaUnknown status
Hospital Universitario de Badajoz
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BadajozSpainUnknown status
Hospital de Sant Joan Despí - Moises Broggi
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BarcelonaSpainUnknown status
Hospital Puerta de Hierro - Hospital Universitario
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MajadahondaSpainUnknown status
Hospital Universitario Donostia
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San SebastiánSpainUnknown status
Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias
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VigoSpainUnknown status
Royal Bournemouth Hospital
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BournemouthUnited KingdomUnknown status
St Thomas Hospital
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LondonUnited KingdomUnknown status
St Georges Hospital London
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LondonUnited KingdomUnknown status
Semmelweis University
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BudapestHungaryUnknown status
Bnai Zion Medical Israel
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HaifaIsraelUnknown status
Advance Medicare Research Institute (AMRI) Hospital
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DhakuriaIndiaUnknown status
Max Super Specialty Hospital
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New DelhiIndiaUnknown status
C.D.C. Citta di Aprilia
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ApriliaItalyUnknown status
Az.Osp.Universitaria Consorziale Policlinico
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BariItalyUnknown status
Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia
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FoggiaItalyUnknown status
Presidio Ospedaliero Giovan Battista Grassi
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Ostia AnticaItalyUnknown status
Casa di Cura Dpott. Pederzoli
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Peschiera del GardaItalyUnknown status
Arcispedale Santa Maria Nuova
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Reggio EmiliaItalyUnknown status
Ospedale S. Andrea
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RomaItalyUnknown status
Policlinico Casilino
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RomaItalyUnknown status
Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
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RomaItalyUnknown status
Saiseikai Fukuoka General Hospital
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FukuokaJapanUnknown status
Seirei Hamamatsu General Hospital
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HamamatsuJapanUnknown status
Akashi Medical Center
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HyōgoJapanUnknown status
St. Marianna University School of Medicine - Toyoko Hospital
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KawasakiJapanUnknown status
University Hospital of Occupational & Environmental Health
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KitakyushuJapanUnknown status
Kokura Memorial Hospital
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KitakyushuJapanUnknown status
Iwate Prefectural Central Hospital
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MoriokaJapanUnknown status
Osaka University Hospital
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SuitaJapanUnknown status
Yokohamashintoshi Neurosurgical Hospital
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YokohamaJapanUnknown status
Hallym University Sacred Heart Hospital
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AnyangSouth KoreaUnknown status
Kosin University Gospel Hospital
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BusanSouth KoreaUnknown status
Dong-A University Hospital
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BusanSouth KoreaUnknown status
Keimyung University - Dongsan Medical Center
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DaeguSouth KoreaUnknown status
Inha University Hospital
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JungguSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Centre
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Chung ang University Hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Sabah Al-Ahmad Cardiac Centre
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Kuwait CityKuwaitUnknown status
Pauls Stradins Clinical University Hospital
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RigaLatviaUnknown status
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsUnknown status
Martini Ziekenhuis
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GroningenNetherlandsUnknown status
Erasmus MC - Thoraxcenter
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RotterdamNetherlandsUnknown status
Haga Ziekenhuis Locatie Leyenburg
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The HagueNetherlandsUnknown status
Maxima Medisch Centrum
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VeldhovenNetherlandsUnknown status
Caribbean Heart Institute
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CaguasPuerto RicoUnknown status
Hospital Prof. Doutor Fernando Fonseca
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AmadoraPortugalUnknown status
Hospital de Santa Cruz
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CarnaxidePortugalUnknown status
Centro Hospitalar do Alto Ave, Unidade de Guimarães
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CreixomilPortugalUnknown status
Hospital de Santo Andre - Centro Hospitalar de Leiria
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LeiriaPortugalUnknown status
Santa Maria Hospital
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LisbonPortugalUnknown status
King Fahad Armed Forces Hospital
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JeddahSaudi ArabiaUnknown status
King Abdullah Medical City in Holy Capital
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MeccaSaudi ArabiaUnknown status
King Fahad Medical City
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RiyadhSaudi ArabiaUnknown status
Changi General Hospital
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SingaporeSingaporeUnknown status
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
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Banská BystricaSlovakiaUnknown status
The National Institute of Cardiovascular Diseases
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BratislavaSlovakiaUnknown status
Ascension Texas Cardiovascular
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AustinUnited StatesUnknown status
St. Luke's Regional Medical Center
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BoiseUnited StatesUnknown status
Bay Area Cardiology Associates PA
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BrandonUnited StatesUnknown status
Erlanger Medical Center
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ChattanoogaUnited StatesUnknown status
Kootenai Heart Clinics
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Coeur d'AleneUnited StatesUnknown status
Cardiology Consultants of East Michigan
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FlintUnited StatesUnknown status
Pinnacle Health System
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HarrisburgUnited StatesUnknown status
MedStar Health Research Institute
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HyattsvilleUnited StatesUnknown status
Arrhythmia Research Group
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JonesboroUnited StatesUnknown status
St. Thomas Hospital
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NashvilleUnited StatesUnknown status
Kansas City Cardiac Arrhythmia Research Foundation
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Overland ParkUnited StatesUnknown status
Adventist HealthCare White Oak Medical Center
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Silver SpringUnited StatesUnknown status
Bayfront Medical Center
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St. PetersburgUnited StatesUnknown status
Iowa Heart Center
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West Des MoinesUnited StatesUnknown status
Cardiology Consultants of Philadelphia
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YardleyUnited StatesUnknown status
Groote Schuur Hospital
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Cape TownSouth AfricaUnknown status
MedClinic Panorama
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Cape TownSouth AfricaUnknown status
Unitas Hospital
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CenturionSouth AfricaUnknown status
Busamed Hillcrest Private Hospital
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HillcrestSouth AfricaUnknown status
Sunninghill Hospital
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JohannesburgSouth AfricaUnknown status
Busamed Gateway Private Hospital
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UmhlangaSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.