DEtermining Accuracy and TrEnding CharacTerization of AF

February 1, 2019 updated by: Abbott Medical Devices
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Neustadt, Germany
        • Rhön-Klinikum, Herz- und Gefäß-Klinik
      • Bad Oeynhausen, Germany, 32545
        • Herz -und Diabeteszentrum
      • Berlin, Germany
        • Charité, Campus Virchow-Klinikum
      • Coburg, Germany
        • Klinikum Coburg
      • Dresden, Germany
        • University of Dresden - Heart Center
      • Frankfurt, Germany
        • Klinikum Frankfurt Höchst GmbH
      • Ingolstadt, Germany, 85049
        • Klinikum Ingolstadt GmbH
      • Leipzig, Germany
        • Herzzentrum Leipzig
      • Munich, Germany, 80331
        • Isar Heart Center
      • Singen, Germany
        • Hegau-Bodensee-Kliniken
      • Villingen Schwenningen, Germany
        • Schwarzwald-Baar Klinikum GmbH
  • Netherlands
      • Den Haag, Netherlands
        • Hagahospital
      • Dordrecht, Netherlands
        • Albert Schweitzer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

  • The subject has been implanted with a SJM Confirm ICM, DM2102.
  • The subject has or is suspected to have paroxysmal AF.
  • The subject is ≥ 18 years of age.
  • The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).

Exclusion Criteria:

  • The subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to restore sinus rhythm).
  • The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
  • The subject has a contraindication to Holter recording.
  • The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
  • The subject is unable to comply with the follow up schedule.
  • The subject is participating in another investigational device or drug investigation.
  • The subject is pregnant or is planning to become pregnant during the duration of the investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SJM Confirm ICM Observational Group
Device: SJM Confirm ICM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
Time Frame: 4 days after Holter starts

Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.

Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
4 days after Holter starts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Thorsten Lewalter, MD, Isar Heart Center Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (ESTIMATE)

August 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DETECT AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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