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Optimal Sensing in Atrial Tachyarrhythmia's Study (OSAT)

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ClinicalTrials.gov Identifier: NCT01074749
Recruitment Status : Terminated (Interim analysis indicated that endpoints can not be analysed with current dataset.)
First Posted : February 24, 2010
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Sick Sinus Syndrome Paroxysmal Atrial Fibrillation Device: Accent Pacemaker Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
Study Start Date : July 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of undersensing of paroxysmal AF and AT from Holter recording. [ Time Frame: 1-3 months ]

Secondary Outcome Measures :
  1. Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm. [ Time Frame: 1-3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074749


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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01074749     History of Changes
Other Study ID Numbers: CR-09-058-ND-LV
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

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

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