Confirm Rx Insertable Cardiac Monitor SMART Registry

Atrial Fibrillation Clinical Trial

Official title:

Confirm Rx Insertable Cardiac Monitor SMART Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03505801
• Other study ID #: SJM-CIP-10176
• Status: Active, not recruiting
• Start date: April 24, 2018
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1826
• Est. completion date: March 31, 2026
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmias
• Symptoms and Signs

Intervention

Device:
• Confirm Rx ICM insertion procedure
Insertion of Confirm Rx ICM device

Locations

Country	Name	City	State
Algeria	Hôpital Central de l'Armée	Algier
Argentina	Instituto Argentino de Diagnostico y Tratamiento	Buenos Aires
Argentina	Clinica Provincial	Merlo
Austria	Kepler Universitätsklinikum GmbH	Linz
Austria	Krankenhaus der Stadt St. Pölten	Sankt Pölten
Austria	Universitätsklinikum Tulln	Tulln
Belgium	Hopital Erasme	Brussels
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	CHU Liège Sart Tilman	Liège
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
Canada	CHUM	Montréal
Canada	Institut de Cardiologie de Quebec (Hospital Laval)	Quebec
Canada	HSC, Eastern Health	Saint John's
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim
Germany	Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin
Germany	Klinikum Coburg GmbH	Coburg
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Klinikum Furth	Fürth
Germany	Asklepios Klinik St. Georg	Hamberg
Germany	Klinikum Herford	Herford
Germany	Klinikum Idar-Oberstein GmbH	Idar-Oberstein	Hesse
Germany	Evangelisches Krankenhaus Kalk gGmbH	Köln
Germany	Krankenhaus Porz am Rhein	Köln
Germany	Medizinische Einrichtungen der Universität zu Köln	Köln
Germany	Universitätsklinikum Leipzig AÖR	Leipzig
Germany	St.-Marien-Hospital GmbH	Lünen
Germany	München Grosshadern	München
Germany	Harzklinikum Dorothea Christiane Erxleben GmbH	Quedlinburg
Germany	Kliniken Villingen-Schwenningen	Villingen-Schwenningen
Hungary	Semmelweis University	Budapest	Budapst
India	Advance Medicare Research Institute (AMRI) Hospital	Dhakuria
India	Max Super Specialty Hospital	New Delhi
Israel	Bnai Zion Medical Israel	Haifa
Italy	C.D.C. Citta di Aprilia	Aprilia
Italy	Az.Osp.Universitaria Consorziale Policlinico	Bari
Italy	Azienda Ospedaliero Universitaria - Ospedali Riuniti Foggia	Foggia	Apulia
Italy	Presidio Ospedaliero Giovan Battista Grassi	Ostia
Italy	Casa di Cura Dpott. Pederzoli	Peschiera Del Garda
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia	Emilia-Romagna
Italy	Ospedale S. Andrea	Roma
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli di Roma	Roma
Italy	Policlinico Casilino	Roma
Japan	Saiseikai Fukuoka General Hospital	Fukuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuok
Japan	Akashi Medical Center	Hyogo
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	Yokohamashintoshi Neurosurgical Hospital	Yokohama	Kanagwa
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeongi
Korea, Republic of	Dong-A University Hospital	Busan	South Gyeongsang Province
Korea, Republic of	Kosin University Gospel Hospital	Busan	Yeongnm
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Inha University Hospital	Junggu	Gyeongi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Sudogwn
Korea, Republic of	Asan Medical Centre	Seoul
Korea, Republic of	Chung Ang University Hospital	Seoul	Sudogwn
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan-si	Yeongnm
Kuwait	Sabah Al-Ahmad Cardiac Centre	Kuwait
Latvia	Pauls Stradins Clinical University Hospital	Riga
Netherlands	Haga Ziekenhuis Locatie Leyenburg	Den Haag
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Erasmus MC - Thoraxcenter	Rotterdam
Netherlands	Maxima Medisch Centrum	Veldhoven
Portugal	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	Lisboa
Puerto Rico	Caribbean Heart Institute	Caguas
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah
Saudi Arabia	King Abdullah Medical City in Holy Capital	Mecca
Saudi Arabia	King Fahad Medical City	Riyadh
Slovakia	Stredoslovenský ústav srdcových a cievnych chorôb, a.s.	Banská Bystrica	Stredne
Slovakia	The National Institute of Cardiovascular Diseases	Bratislava
South Africa	Groote Schuur Hospital	Cape Town	W Cape
South Africa	MedClinic Panorama	Cape Town	W Cape
South Africa	Unitas Hospital	Centurion
South Africa	Busamed Hillcrest Private Hospital	Hillcrest
South Africa	Sunninghill Hospital	Johannesburg	Sandton
South Africa	Busamed Gateway Private Hospital	Umhlanga
Spain	Hospital Universitario de Badajoz	Badajoz	Extmdra
Spain	Hospital Universitario Infanta Cristina	Badajoz
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
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	St Georges Hospital London	London
United Kingdom	St. Thomas Hospital	London
United States	Ascension Texas Cardiovascular	Austin	Texas
United States	Seton Medical Center	Austin	Texas
United States	St. Luke's Regional Medical Center	Boise	Idaho
United States	Bay Area Cardiology Associates PA	Brandon	Florida
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Kootenai Heart Clinics	Coeur d'Alene	Idaho
United States	Cardiology Consultants of East Michigan	Flint	Michigan
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Adventist HealthCare White Oak Medical Center	Silver Spring	Maryland
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Austria,  Belgium,  Canada,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Kuwait,  Latvia,  Netherlands,  Portugal,  Puerto Rico,  Saudi Arabia,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device SADEs and serious procedure related SAEs		1 month post insertion procedure
Secondary	Freedom from device SADEs and serious procedure related SAEs		12 months post insertion procedure
Secondary	R wave amplitude		12 months post insertion procedure