Registro SMART del Monitor Cardíaco Insertable Confirm Rx

Activo, no reclutaClinicalTrials.gov

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

Resumen

El propósito del Registro SMART de Confirm Rx es recopilar datos del mundo real para evaluar la seguridad y el desempeño del Monitor Cardíaco Insertable (MCI) Confirm Rx y su sistema durante un período de 12 meses. Un subgrupo de participantes incluidos en el Registro SMART de Confirm Rx cumplirá con el requisito de Seguimiento Clínico Poscomercialización (PMCF) para la marca CE.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

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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