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DEtermining Accuracy and TrEnding CharacTerization of AF

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: August 22, 2012
Last updated: March 16, 2015
Last verified: March 2015
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).

Condition Intervention
Atrial Fibrillation
Device: SJM Confirm ICM

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DEtermining Accuracy and TrEnding CharacTerization of AF

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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.

Enrollment: 90
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SJM Confirm ICM Observational Group Device: SJM Confirm ICM


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01673256

Rhön-Klinikum, Herz- und Gefäß-Klinik
Bad Neustadt, Germany
Herz -und Diabeteszentrum
Bad Oeynhausen, Germany, 32545
Charite, Campus Virchow-Klinikum
Berlin, Germany
Klinikum Coburg
Coburg, Germany
University of Dresden - Heart Center
Dresden, Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt, Germany
Klinikum Ingolstadt GmbH
Ingolstadt, Germany, 85049
Herzzentrum Leipzig
Leipzig, Germany
Isar Heart Center
Munich, Germany, 80331
Singen, Germany
Schwarzwald-Baar Klinikum GmbH
Villingen Schwenningen, Germany
Den Haag, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Thorsten Lewalter, MD Isar Heart Center Munich
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01673256     History of Changes
Other Study ID Numbers: DETECT AF
Study First Received: August 22, 2012
Results First Received: January 5, 2015
Last Updated: March 16, 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 26, 2017