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Confirm Rx SMART Registry

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ClinicalTrials.gov Identifier: NCT03505801
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment
Cardiac Arrhythmias Symptoms and Signs Atrial Fibrillation Device: Confirm Rx ICM insertion procedure

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Confirm Rx Insertable Cardiac Monitor SMART Registry
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Freedom from device SADEs and serious procedure related SAEs [ Time Frame: 1 month post insertion procedure ]

Secondary Outcome Measures :
  1. Freedom from device SADEs and serious procedure related SAEs [ Time Frame: 12 months post insertion procedure ]
  2. R wave amplitude [ Time Frame: 12 months post insertion procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505801


Contacts
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Contact: Pascale Ducloux 003227746709 pascale.ducloux@abbott.com

Locations
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Italy
Arcispedale Santa Maria Nuova Recruiting
Reggio Emilia, Emilia-Romagna, Italy
Contact: Fabio Quartieri, MD         
Sponsors and Collaborators
Abbott Medical Devices

Additional Information:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03505801     History of Changes
Other Study ID Numbers: SJM-CIP-10176
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes