Long-term Pacemaker Arrhythmia Analysis | NCT02016950

Studies
Long-term Pacemaker Arrhythmia Analysis

NCT02016950

Sponsor

Eastbourne General Hospital

Status

Completed

Last Update Posted

Feb 12, 2015Estimated

Enrollment

2,551Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

United Kingdom

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 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Dec 11, 2013

First Submission Date that Met QC Criteria

Dec 16, 2013

First Posted Date

Dec 20, 2013Estimated

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 10, 2015

Last Update Posted Date

Feb 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,551Actual

Label	Type	Description	Intervention Names
Permanent pacemaker		Pre-existing permanent pacemakers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial fibrillation burden	Proportion of monitored time in atrial fibrillation	28 days to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Atrial fibrillation episode frequency		28 days to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pre-existing dual chamber permanent pacemaker

Exclusion Criteria:

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

Those with permanent pacemakers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Sulke, MD	Eastbourne General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastbourne General Hospital		Eastbourne	E Sussex	BN21 2UD	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26023175	Derived	Sugihara C, Veasey R, Freemantle N, Podd S, Furniss S, Sulke N. The development of AF over time in patients with permanent pacemakers: objective assessment with pacemaker diagnostics demonstrates distinct patterns of AF. Europace. 2015 Jun;17(6):864-70. doi: 10.1093/europace/euv032.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes