DEtermining Accuracy and TrEnding CharacTerization of AF

This study is currently recruiting participants.
Verified October 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01673256
First received: August 22, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The objective of this study is to assess the AF episode detection when using the SJM Confirm ICM.


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 Confirm ICM 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SJM Confirm ICM Observational Group Device: SJM Confirm ICM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673256

Contacts
Contact: Kyle Brunner 651-756-3482 Kbrunner02@sjm.com

Locations
Germany
Herz -und Diabeteszentrum Active, not recruiting
Bad Oeynhausen, Germany, 32545
Charite, Campus Virchow-Klinikum Recruiting
Berlin, Germany
Contact: Katja Hubert    +4930450676816      
Principal Investigator: Leif-Hendrik Boldt, Dr.         
Klinikum Coburg Recruiting
Coburg, Germany
Contact: Petra Denninger    +499561226344      
Principal Investigator: Johannes Brachmann, Prof. Dr.         
University of Dresden - Heart Center Recruiting
Dresden, Germany
Contact: Christopher Piorkowski, Dr.    +493514501903      
Principal Investigator: Christopher Piorkowski, PD Dr.         
Klinikum Frankfurt Höchst GmbH Recruiting
Frankfurt, Germany
Contact: Thomas Massa, Dr.       thomas.massa@klinikumfrankfurt.de   
Principal Investigator: Thomas Massa, Dr.         
Klinikum Ingolstadt GmbH Recruiting
Ingolstadt, Germany, 85049
Contact: Monika-Krista Zackel    +49 841 8809593      
Principal Investigator: Karlheinz Seidl, Prof. Dr.         
Herzzentrum Leipzig Recruiting
Leipzig, Germany
Contact: Katja Palm    +49 341 865 1581      
Principal Investigator: Gerhard Hindricks, Prof. Dr.         
Isar Heart Center Recruiting
Munich, Germany, 80331
Contact: Monika Neumeyer    +49 89 149903 6051      
Principal Investigator: Thorsten Lewalter, Prof. Dr.         
Hegau-Bodensee-Kliniken Recruiting
Singen, Germany
Contact: Marc Kollum, Dr    +497731892600      
Principal Investigator: Marc Kollum, Dr.         
Schwarzwald-Baar Klinikum GmbH Recruiting
Villingen Schwenningen, Germany
Contact: Julia Ringgenburger    +49 7721 93 3028      
Principal Investigator: Werner Jung, Prof. Dr.         
Netherlands
Hagahospital Recruiting
Den Haag, Netherlands
Contact: Marijke Hugo    +31702104903      
Principal Investigator: Vincent van Driel, Dr         
Albert Schweitzer Hospital Recruiting
Dordrecht, Netherlands
Contact: Leon van Woerkens, Dr         
Principal Investigator: Leon van Woerkens, Dr.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Thorsten Lewalter, MD Isar Heart Center Munich
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01673256     History of Changes
Other Study ID Numbers: DETECT AF
Study First Received: August 22, 2012
Last Updated: October 25, 2013
Health Authority: Germany: Ethics Commission
Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014