Smart Phone Atrial Fibrillation Application | NCT04354506

Studies
Smart Phone Atrial Fibrillation Application

NCT04354506

Sponsor

Institute of Longevity

Status

Unknown status

Last Update Posted

Apr 21, 2020Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Not provided

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Estimated

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Apr 17, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 21, 2020Actual

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

Apr 17, 2020

Last Update Posted Date

Apr 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dimitris Tsiachris, Electrophysiology and Pacing Lab Director, Athens Heart Center, Institute of LongevityPrincipal Investigator

Lead Sponsor

Institute of LongevityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial fibrillation recurrence	Clinical episodes of atrial fibrillation, hospitalisation for atrial fibrillation	1 year

Secondary Outcomes

Measure	Description	Time Frame
Stroke incidence	Ischemic or hemorrhagic stroke	1 year
Major bleeding incidence	GI bleeding, urinary bleeding necessitating hospitalisation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Paroxysmal or persistent atrial fibrillation

Exclusion Criteria:

unable to provide informed consent unable to have 1 year of follow-up for any reason

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

All eligible patients downloading specific AF mobile technology application

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dimitris Tsiachris, MD, PHD	Contact	+306944849926		dtsiachris@yahoo.com
Athanasios Kordalis, MD, PHD	Contact	6972225950		akordalis@gmail.com

Overall Officials

Name	Affiliation	Role
Dimitris Tsiachris, MD, PHD	Institute of Longevity	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided