Optimal Sensing in Atrial Tachyarrhythmia's Study (OSAT)

February 1, 2019 updated by: Abbott Medical Devices

OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Lucas Andreas Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of undersensing of paroxysmal AF and AT from Holter recording.
Time Frame: 1-3 months
1-3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Willem De Voogt, MD PhD, St Lucas Andreas Hospital Amsterdam, Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-09-058-ND-LV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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