DEtermining Accuracy and TrEnding CharacTerization of AF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01673256
First received: August 22, 2012
Last updated: May 1, 2014
Last verified: May 2014
  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 ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Hegau-Bodensee-Kliniken
Singen, Germany
Schwarzwald-Baar Klinikum GmbH
Villingen Schwenningen, Germany
Netherlands
Hagahospital
Den Haag, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
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: May 1, 2014
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 July 24, 2014