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Confirm Rx Insertable Cardiac Monitor SMART Registry

NCT03505801 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1826

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Confirm Rx ICM insertion procedure

Insertion of Confirm Rx ICM device

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Fabio Quartieri, MD · Arcispedale S. Maria Nuova - IRCCS l

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2019-09-19
Completion
2026-01-06

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505801 on ClinicalTrials.gov