Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confirm Rx ICM insertion procedure | Device | Insertion of Confirm Rx ICM device |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from device SADEs and serious procedure related SAEs | 1 month post insertion procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from device SADEs and serious procedure related SAEs | 12 months post insertion procedure | |
| R wave amplitude | 12 months post insertion procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabio Quartieri, MD | Arcispedale S. Maria Nuova - IRCCS l | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States | ||
| Bay Area Cardiology Associates PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40514061 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D012816 | Signs and Symptoms |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided