Confirm Rx™ SMART Registry
Research type
Research Study
Full title
Confirm Rx™ Insertable Cardiac Monitor SMART Registry
IRAS ID
242089
Contact name
Joanne O'Beirne-Elliman
Contact email
Sponsor organisation
Abbott Medical U.K. Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 29 days
Research summary
This is a prospective, single arm, multi-centre study of patients with a Confirm Rx™ ICM (Insertable Cardiac Monitor) device inserted. The purpose of the study is to assess the safety and performance of the Confirm Rx™ ICM and its components. The Confirm Rx™ ICM device is intended for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias (abnormal heart beat). It is also indicated for patients who have been previously diagnosed with atrial fibrillation (fast heart beat) or who are prone to developing atrial fibrillation. The study will be conducted in approximately 100 centres worldwide and up to 2000 patients will be enrolled. Participants will be in the study for 12 months and there are three follow up visits.
Some patients with AF true detection will be invited to participate in the sub-study where they will have additional follow-up for between 2-7 days. Sub-study participants will be asked to wear a Holter monitor for 4 consecutive days, with the aim of measuring the performance of the Confirm Rx device for diagnosing AF in patients that have had AF detected post-enrolment , compared with the Holter monitor. Once written consent is maintained, these patients will have an additional in-clinical follow-up visit arranged for at least 48 hours –to 4 days after the 1-month visit.REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0464
Date of REC Opinion
12 Sep 2019
REC opinion
Further Information Favourable Opinion