Optimal Sensing in Atrial Tachyarrhythmia's Study (OSAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01074749
First received: February 22, 2010
Last updated: July 29, 2013
Last verified: July 2013
  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:


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 2014
Estimated Primary Completion Date: April 2014 (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 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
  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: 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
  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: July 29, 2013
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
Tachycardia
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on September 16, 2014