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Optimal Sensing in Atrial Tachyarrhythmia's Study (OSAT)

This study is currently recruiting participants.
Verified August 2012 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01074749
First received: February 22, 2010
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).


Condition Intervention
Sick Sinus Syndrome
Paroxysmal Atrial Fibrillation
 Device: Accent Pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Number of undersensing of paroxysmal AF and AT from Holter recording. [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm. [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 158
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Optisense lead
Patients with an Accent pacemaker and an OptiSense atrial lead
 Device: Accent Pacemaker
Implantation of pacemaker
Other Names:
  • Accent DR RF 2212 Pacemaker
  • OptiSense 1999 atrial lead
Active Comparator: Tendril lead
Patients with an Accent pacemaker and a Tendril atrial lead
 Device: Accent Pacemaker
Implantation of pacemaker
Other Names:
  • Accent DR RF 2212 Pacemaker
  • OptiSense 1999 atrial lead

Detailed Description:

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with class I or II pacing indications for Sick Sinus Syndrome with documented paroxysmal atrial tachyarrhythmias over the last 6 months
  • Signed informed consent
  • Age >18 yrs

Exclusion Criteria:

  • Severe valvular heart disease (echocardiogram less than 6 months old)
  • Angina Pectoris class ≥ III
  • Congestive heart failure - NYHA class ≥ III
  • Left Ventricular Ejection Fraction < 35% (less than 6 months old)
  • Hypertrophic Cardiomyopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074749

Locations
Netherlands
Lucas Andreas Ziekenhuis Recruiting
Amsterdam, Netherlands
Contact: Willem De Voogt, MD     +31205108911        
Principal Investigator: Willem De Voogt, PhD, MD            
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Willem De Voogt, MD PhD St Lucas Andreas Hospital Amsterdam, Netherlands
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01074749     History of Changes
Other Study ID Numbers: CR-09-058-ND-LV
Study First Received: February 22, 2010
Last Updated: August 20, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by St. Jude Medical:
AF
Automatic Mode Switch
FFRW
paroxysmal AF

Additional relevant MeSH terms:
Atrial Fibrillation
Sick Sinus Syndrome
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on June 18, 2013