Confirm Rx Insertable Cardiac Monitor SMART Registry
- Conditions
- Cardiac ArrhythmiasAtrial FibrillationSymptoms and Signs
- Registration Number
- NCT03505801
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1826
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from device SADEs and serious procedure related SAEs 1 month post insertion procedure
- Secondary Outcome Measures
Name Time Method Freedom from device SADEs and serious procedure related SAEs 12 months post insertion procedure R wave amplitude 12 months post insertion procedure
Trial Locations
- Locations (111)
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Cardiology Consultants of Philadelphia
🇺🇸Yardley, Pennsylvania, United States
Pinnacle Health System
🇺🇸Harrisburg, Pennsylvania, United States
Hospital Universitario Donostia
🇪🇸San Sebastián, Spain
Hospital Puerta de Hierro - Hospital Universitario
🇪🇸Majadahonda, Spain
Kansas City Cardiac Arrhythmia Research Foundation
🇺🇸Overland Park, Kansas, United States
Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia
🇮🇹Foggia, Apulia, Italy
Osaka University Hospital
🇯🇵Suita, Japan
Kepler Universitätsklinikum GmbH
🇦🇹Linz, Austria
Krankenhaus der Stadt St. Pölten
🇦🇹Sankt Pölten, Austria
Max Super Specialty Hospital
🇮🇳New Delhi, India
Klinikum Idar-Oberstein GmbH
🇩🇪Idar-Oberstein, Hesse, Germany
Sabah Al-Ahmad Cardiac Centre
🇰🇼Kuwait, Kuwait
Hospital Prof. Doutor Fernando Fonseca
🇵🇹Amadora, Portugal
Stredoslovenský ústav srdcových a cievnych chorôb, a.s.
🇸🇰Banská Bystrica, Stredne, Slovakia
The National Institute of Cardiovascular Diseases
🇸🇰Bratislava, Slovakia
Hôpital Central de l'Armée
🇩🇿Algier, Algeria
Advance Medicare Research Institute (AMRI) Hospital
🇮🇳Dhakuria, India
Santa Maria Hospital
🇵🇹Lisboa, Portugal
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
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
Semmelweis University
🇭🇺Budapest, Budapst, Hungary
King Abdullah Medical City in Holy Capital
🇸🇦Mecca, Saudi Arabia
King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
Bay Area Cardiology Associates PA
🇺🇸Brandon, Florida, United States
St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Kootenai Heart Clinics
🇺🇸Coeur d'Alene, Idaho, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Adventist HealthCare White Oak Medical Center
🇺🇸Silver Spring, Maryland, United States
MedStar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
Cardiology Consultants of East Michigan
🇺🇸Flint, Michigan, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
St. Thomas Hospital
🇬🇧London, United Kingdom
Instituto Argentino de Diagnostico y Tratamiento
🇦🇷Buenos Aires, Argentina
CHU Liège Sart Tilman
🇧🇪Liège, Belgium
Universitätsklinikum Tulln
🇦🇹Tulln, Austria
Hopital Erasme
🇧🇪Brussels, Belgium
Clinica Provincial
🇦🇷Merlo, Argentina
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
HSC, Eastern Health
🇨🇦Saint John's, Canada
CHUM
🇨🇦Montréal, Canada
Institut de Cardiologie de Quebec (Hospital Laval)
🇨🇦Quebec, Canada
Kerckhoff-Klinik gGmbH
🇩🇪Bad Nauheim, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Germany
Klinikum Furth
🇩🇪Fürth, Germany
Klinikum Herford
🇩🇪Herford, Germany
Evangelisches Krankenhaus Kalk gGmbH
🇩🇪Köln, Germany
Medizinische Einrichtungen der Universität zu Köln
🇩🇪Köln, Germany
Asklepios Klinik St. Georg
🇩🇪Hamberg, Germany
Krankenhaus Porz am Rhein
🇩🇪Köln, Germany
Universitätsklinikum Leipzig AÖR
🇩🇪Leipzig, Germany
München Grosshadern
🇩🇪München, Germany
St.-Marien-Hospital GmbH
🇩🇪Lünen, Germany
Casa di Cura Dpott. Pederzoli
🇮🇹Peschiera Del Garda, Italy
Kliniken Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
🇩🇪Quedlinburg, Germany
Bnai Zion Medical Israel
🇮🇱Haifa, Israel
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, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
🇮🇹Roma, Italy
Ospedale S. Andrea
🇮🇹Roma, Italy
Policlinico Casilino
🇮🇹Roma, Italy
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuok, Japan
Yokohamashintoshi Neurosurgical Hospital
🇯🇵Yokohama, Kanagwa, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoka, Japan
Akashi Medical Center
🇯🇵Hyōgo, Japan
Caribbean Heart Institute
🇵🇷Caguas, Puerto Rico
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
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Gyeongi, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, South Gyeongsang Province, Korea, Republic of
Inha University Hospital
🇰🇷Junggu, Gyeongi, Korea, Republic of
Chung Ang University Hospital
🇰🇷Seoul, Sudogwn, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Sudogwn, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan-si, Yeongnm, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Yeongnm, Korea, Republic of
Asan Medical Centre
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Haga Ziekenhuis Locatie Leyenburg
🇳🇱Den Haag, Netherlands
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
Erasmus MC - Thoraxcenter
🇳🇱Rotterdam, Netherlands
King Fahad Armed Forces Hospital
🇸🇦Jeddah, Saudi Arabia
Busamed Hillcrest Private Hospital
🇿🇦Hillcrest, South Africa
Busamed Gateway Private Hospital
🇿🇦Umhlanga, South Africa
Sunninghill Hospital
🇿🇦Johannesburg, Sandton, South Africa
MedClinic Panorama
🇿🇦Cape Town, W Cape, South Africa
Unitas Hospital
🇿🇦Centurion, South Africa
Groote Schuur Hospital
🇿🇦Cape Town, W Cape, South Africa
Hospital Universitario de Badajoz
🇪🇸Badajoz, Extmdra, Spain
Hospital de Sant Joan Despí Moisès Broggi
🇪🇸Barcelona, Spain
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
St Georges Hospital London
🇬🇧London, United Kingdom
Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias
🇪🇸Vigo, Spain
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ascension Texas Cardiovascular
🇺🇸Austin, Texas, United States