Optimal Sensing in Atrial Tachyarrhythmia's Study | NCT01074749

Studies
Optimal Sensing in Atrial Tachyarrhythmia's Study

NCT01074749

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

111Actual

Phase

Not Applicable

Conditions

Sick Sinus Syndrome
Paroxysmal Atrial Fibrillation

Interventions

Accent Pacemaker

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis indicated that endpoints can not be analysed with current dataset.

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Apr 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Feb 22, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optisense lead	Active Comparator	Patients with an Accent pacemaker and an OptiSense atrial lead	Device: Accent Pacemaker
Tendril lead	Active Comparator	Patients with an Accent pacemaker and a Tendril atrial lead	Device: Accent Pacemaker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Accent Pacemaker	Device	Implantation of pacemaker	Optisense lead Tendril lead

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Willem De Voogt, MD PhD	St Lucas Andreas Hospital Amsterdam, Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lucas Andreas Ziekenhuis		Amsterdam			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34599455	Derived	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.

ID	Term
D001146	Arrhythmia, Sinus
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D012804	Sick Sinus Syndrome
D001281	Atrial Fibrillation