Study of New Implantable Loop Recorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00746564
First received: September 2, 2008
Last updated: June 4, 2013
Last verified: June 2013

September 2, 2008
June 4, 2013
September 2008
February 2011   (final data collection date for primary outcome measure)
Data collection of implantable loop recordings. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00746564 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of New Implantable Loop Recorder
Confirm Implantable Cardiac Monitor Study

The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the SJM Confirm Implantable Cardiac Monitor (device).

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Tachyarrhythmias
  • Syncope
Device: SJM Confirm
All patients in this study will receive the SJM Confirm device.
Experimental: Open Label
Intervention: Device: SJM Confirm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
December 2013
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
  • Patients who experience transient symptoms that may suggest a cardiac arrhythmia
  • Patients who have been previously diagnosed with atrial fibrillation
  • Patients who are suspected to have AF but AF has not been documented
  • Patients who have provided written informed consent to participate in the study.

Exclusion Criteria:

  • Patients who are under the age of 18 years
  • Patients who have a life expectancy less than 1 year
  • Patients who are unable to comply with the follow-up schedule
  • Patients who are currently implanted with a pacemaker or defibrillator
  • Patients who the physician deems inappropriate for the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746564
60020941D
No
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: Tamara Shipman St. Jude Medical
St. Jude Medical
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP