Optimal Sensing in Atrial Tachyarrhythmia's Study - Full Text View

Sponsor:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01074749

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

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:	July 2012
Estimated Primary Completion Date:	April 2012 (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 documented 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074749

Locations

Netherlands
Lucas Andreas Ziekenhuis	Recruiting
Amsterdam, Netherlands
Contact: Willem De Voogt, MD +31205108911
Principal Investigator: Willem De Voogt, PhD, MD

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:	Marc Hubregtse, Clinical Project Leader St Jude Medical Netherlands, St Jude Medical Nederland
ClinicalTrials.gov Identifier:	NCT01074749 History of Changes
Other Study ID Numbers:	CR-09-058-ND-LV
Study First Received:	February 22, 2010
Last Updated:	February 22, 2011
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
Sick Sinus Syndrome
Tachycardia
Arrhythmias, Cardiac
Heart Diseases

Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on May 23, 2012