Clinical trial NCT03505801: Confirm Rx Insertable Cardiac Monitor SMART Registry
Official title: Confirm Rx Insertable Cardiac Monitor SMART Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Arrhythmias
Symptoms and Signs
Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 1826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Freedom from device SADEs and serious procedure related SAEs
timeFrame: 1 month post insertion procedure
Secondary outcomes:
measure: Freedom from device SADEs and serious procedure related SAEs
timeFrame: 12 months post insertion procedure
measure: R wave amplitude
timeFrame: 12 months post insertion procedure
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Brandon
country: United States
facility: Bay Area Cardiology Associates PA
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Heart Clinics
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Silver Spring
country: United States
facility: Adventist HealthCare White Oak Medical Center
state: Maryland
city: Flint
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: Ascension Texas Cardiovascular
state: Texas
city: Algier
country: Algeria
facility: Hôpital Central de l'Armée
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnostico y Tratamiento
city: Merlo
country: Argentina
facility: Clinica Provincial
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
city: Sankt Pölten
country: Austria
facility: Krankenhaus der Stadt St. Pölten
city: Tulln
country: Austria
facility: Universitätsklinikum Tulln
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Liège
country: Belgium
facility: CHU Liège Sart Tilman
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Montréal
country: Canada
facility: CHUM
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (Hospital Laval)
city: Saint John's
country: Canada
facility: HSC, Eastern Health
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein GmbH
state: Hesse
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Fürth
country: Germany
facility: Klinikum Furth
city: Hamberg
country: Germany
facility: Asklepios Klinik St. Georg
city: Herford
country: Germany
facility: Klinikum Herford
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk gGmbH
city: Köln
country: Germany
facility: Krankenhaus Porz am Rhein
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universität zu Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AÖR
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: München
country: Germany
facility: München Grosshadern
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
city: Budapest
country: Hungary
facility: Semmelweis University
state: Budapst
city: Dhakuria
country: India
facility: Advance Medicare Research Institute (AMRI) Hospital
city: New Delhi
country: India
facility: Max Super Specialty Hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Israel
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia
state: Apulia
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
state: Emilia-Romagna
city: Aprilia
country: Italy
facility: C.D.C. Citta di Aprilia
city: Bari
country: Italy
facility: Az.Osp.Universitaria Consorziale Policlinico
city: Ostia
country: Italy
facility: Presidio Ospedaliero Giovan Battista Grassi
city: Peschiera Del Garda
country: Italy
facility: Casa di Cura Dpott. Pederzoli
city: Roma
country: Italy
facility: Ospedale S. Andrea
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
city: Roma
country: Italy
facility: Policlinico Casilino
city: Yokohama
country: Japan
facility: Yokohamashintoshi Neurosurgical Hospital
state: Kanagwa
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuok
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Hyōgo
country: Japan
facility: Akashi Medical Center
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine - Toyoko Hospital
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
city: Kitakyushu
country: Japan
facility: University Hospital of Occupational & Environmental Health
city: Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeongi
city: Junggu
country: Korea, Republic of
facility: Inha University Hospital
state: Gyeongi
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: South Gyeongsang Province
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Sudogwn
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
state: Sudogwn
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Yeongnm
city: Ulsan-si
country: Korea, Republic of
facility: Ulsan University Hospital
state: Yeongnm
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Centre
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Kuwait
country: Kuwait
facility: Sabah Al-Ahmad Cardiac Centre
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis Locatie Leyenburg
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thoraxcenter
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Creixomil
country: Portugal
facility: Centro Hospitalar do Alto Ave, Unidade de Guimarães
city: Leiria
country: Portugal
facility: Hospital de Santo Andre - Centro Hospitalar de Leiria
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
city: Caguas
country: Puerto Rico
facility: Caribbean Heart Institute
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
city: Mecca
country: Saudi Arabia
facility: King Abdullah Medical City in Holy Capital
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Banská Bystrica
country: Slovakia
facility: Stredoslovenský ústav srdcových a cievnych chorôb, a.s.
state: Stredne
city: Bratislava
country: Slovakia
facility: The National Institute of Cardiovascular Diseases
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
state: Sandton
city: Cape Town
country: South Africa
facility: MedClinic Panorama
state: W Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: W Cape
city: Centurion
country: South Africa
facility: Unitas Hospital
city: Hillcrest
country: South Africa
facility: Busamed Hillcrest Private Hospital
city: Umhlanga
country: South Africa
facility: Busamed Gateway Private Hospital
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
state: Extmdra
city: Barcelona
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro - Hospital Universitario
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro, Dept of EP & Arrhythmias
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: London
country: United Kingdom
facility: St Georges Hospital London
city: London
country: United Kingdom
facility: St. Thomas Hospital
Study officials:
affiliation: Arcispedale S. Maria Nuova - IRCCS l
name: Fabio Quartieri, MD
role: PRINCIPAL_INVESTIGATOR
References: