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NCT03505801 · ClinicalTrials.gov registry record

Confirm Rx Insertable Cardiac Monitor SMART Registry

A clinical trial of Atrial Fibrillation and Symptoms and Signs, sponsored by Abbott Medical Devices.

Active
Registry status
1,826
Enrollment target
20
Study locations

NCT03505801 is a study of Atrial Fibrillation and Symptoms and Signs that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 1,826 participants, below the 2,988-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03505801, a study of Atrial Fibrillation and Symptoms and Signs, is active but no longer recruiting, sponsored by Abbott Medical Devices.

ACTIVE NOT RECRUITING
Registry status
1,826 participants
Enrollment target
20
Study locations

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 Studied

Atrial Fibrillation Symptoms and Signs Cardiac Arrhythmias

Interventions

  • DEVICE Confirm Rx ICM insertion procedure

Study Locations (20)

Other

  • Hôpital Central de l'Armée - Algiers
  • Instituto Argentino de Diagnostico y Tratamiento - Buenos Aires
  • Clinica Provincial - Merlo
  • Kepler Universitätsklinikum GmbH - Linz
  • Krankenhaus der Stadt St. Pölten - Sankt Pölten

Florida

  • Bay Area Cardiology Associates PA - Brandon
  • Bayfront Medical Center - St. Petersburg

Idaho

  • St. Luke's Regional Medical Center - Boise
  • Kootenai Heart Clinics - Coeur d'Alene

Maryland

  • MedStar Health Research Institute - Hyattsville
  • Adventist HealthCare White Oak Medical Center - Silver Spring

Pennsylvania

  • Pinnacle Health System - Harrisburg
  • Cardiology Consultants of Philadelphia - Yardley

Tennessee

  • Erlanger Medical Center - Chattanooga
  • St. Thomas Hospital - Nashville

Arkansas

  • Arrhythmia Research Group - Jonesboro

Iowa

  • Iowa Heart Center - West Des Moines

Trial Details

FieldValue
Enrollment Target 1,826 participants
Start Date 2018-04-24
Est. Completion 2026-03-31

Sponsor

Abbott Medical Devices

261 total trials

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What the Registry Record Tells You About NCT03505801

The ClinicalTrials.gov registry entry for NCT03505801 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 1,826 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,988-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (39% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Confirm Rx ICM insertion procedure is the first listed.

NCT03505801 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Florida, Idaho.

Frequently Asked Questions

What is clinical trial NCT03505801 about?

NCT03505801 is a clinical study titled "Confirm Rx Insertable Cardiac Monitor SMART Registry". 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 Fol...

What is the current status of trial NCT03505801?

This trial is currently active not recruiting. The enrollment target is 1,826 participants. The study started on 2018-04-24. Estimated completion is 2026-03-31.

What conditions does trial NCT03505801 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Symptoms and Signs, Cardiac Arrhythmias.

What interventions are being tested in trial NCT03505801?

The interventions under investigation include: Confirm Rx ICM insertion procedure (DEVICE).

Who is sponsoring clinical trial NCT03505801?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03505801 being conducted?

This trial has 20 study locations across Arkansas, Florida, Idaho, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.