Confirm Rx Insertable Cardiac Monitor SMART Registry
1 other identifier
observational
1,826
24 countries
113
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2026
CompletedMay 6, 2026
April 1, 2026
1.4 years
April 13, 2018
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from device SADEs and serious procedure related SAEs
1 month post insertion procedure
Secondary Outcomes (2)
Freedom from device SADEs and serious procedure related SAEs
12 months post insertion procedure
R wave amplitude
12 months post insertion procedure
Interventions
Insertion of Confirm Rx ICM device
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (113)
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
Asan Medical Centre
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
Hospital Universitario de Badajoz
Badajoz, Extmdra, Spain
Hospital de Sant Joan Despí Moisès Broggi
Barcelona, Spain
Hospital Puerta de Hierro - Hospital Universitario
Majadahonda, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias
Vigo, Spain
Royal Bournemouth Hospital
Bournemouth, United Kingdom
St Georges Hospital London
London, United Kingdom
St. Thomas Hospital
London, United Kingdom
Related Publications (1)
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.
PMID: 40514061DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Quartieri, MD
Arcispedale S. Maria Nuova - IRCCS l
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2018
First Posted
April 23, 2018
Study Start
April 24, 2018
Primary Completion
September 19, 2019
Study Completion
January 6, 2026
Last Updated
May 6, 2026
Record last verified: 2026-04