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Optimal Sensing in Atrial Tachyarrhythmia's Study (OSAT)

Primary Purpose

Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Accent Pacemaker
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sick Sinus Syndrome focused on measuring AF, Automatic Mode Switch, FFRW, paroxysmal AF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lucas Andreas Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Optisense lead

Tendril lead

Arm Description

Patients with an Accent pacemaker and an OptiSense atrial lead

Patients with an Accent pacemaker and a Tendril atrial lead

Outcomes

Primary Outcome Measures

Number of undersensing of paroxysmal AF and AT from Holter recording.

Secondary Outcome Measures

Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.

Full Information

First Posted
February 22, 2010
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01074749
Brief Title
Optimal Sensing in Atrial Tachyarrhythmia's Study
Acronym
OSAT
Official Title
OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis indicated that endpoints can not be analysed with current dataset.
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
Keywords
AF, Automatic Mode Switch, FFRW, paroxysmal AF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optisense lead
Arm Type
Active Comparator
Arm Description
Patients with an Accent pacemaker and an OptiSense atrial lead
Arm Title
Tendril lead
Arm Type
Active Comparator
Arm Description
Patients with an Accent pacemaker and a Tendril atrial lead
Intervention Type
Device
Intervention Name(s)
Accent Pacemaker
Other Intervention Name(s)
Accent DR RF 2212 Pacemaker, OptiSense 1999 atrial lead
Intervention Description
Implantation of pacemaker
Primary Outcome Measure Information:
Title
Number of undersensing of paroxysmal AF and AT from Holter recording.
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.
Time Frame
1-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem De Voogt, MD PhD
Organizational Affiliation
St Lucas Andreas Hospital Amsterdam, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucas Andreas Ziekenhuis
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34599455
Citation
Pakarinen S, Lehto M, Ruiter J, de Voogt WG. Enhanced detection of atrial tachyarrhythmias with pacing devices by using more accurate atrial sensing. J Interv Card Electrophysiol. 2022 Apr;63(3):601-609. doi: 10.1007/s10840-021-01066-z. Epub 2021 Oct 1.
Results Reference
derived

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Optimal Sensing in Atrial Tachyarrhythmia's Study

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