Confirm Rx Insertable Cardiac Monitor SMART Registry

Activo, no reclutaClinicalTrials.gov

ID: NCT03505801Tipo: OBSERVATIONALInicio: 24 de abr de 2018Fin estimado: 31 de mar de 2026

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.
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.

Criterios de exclusión

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.

Intervenciones

device

Confirm Rx ICM insertion procedure

Insertion of Confirm Rx ICM device

Ubicaciones

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

Clinica Provincial

Merlo, Argentina

Patrocinadores

PrincipalAbbott Medical Devices

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Confirm Rx Insertable Cardiac Monitor SMART Registry | EligiMed