Study Stopped
Interim analysis indicated that endpoints can not be analysed with current dataset.
Optimal Sensing in Atrial Tachyarrhythmia's Study
OSAT
OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
1 other identifier
interventional
111
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFebruary 4, 2019
February 1, 2019
3.8 years
February 22, 2010
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of undersensing of paroxysmal AF and AT from Holter recording.
1-3 months
Secondary Outcomes (1)
Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.
1-3 months
Study Arms (2)
Optisense lead
ACTIVE COMPARATORPatients with an Accent pacemaker and an OptiSense atrial lead
Tendril lead
ACTIVE COMPARATORPatients with an Accent pacemaker and a Tendril atrial lead
Interventions
Implantation of pacemaker
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Related Publications (1)
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.
PMID: 34599455DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Willem De Voogt, MD PhD
St Lucas Andreas Hospital Amsterdam, Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 24, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2014
Study Completion
July 1, 2014
Last Updated
February 4, 2019
Record last verified: 2019-02