Safety of Smartphones Among Patients With Cardiac Implant... | NCT01819896

Studies
Safety of Smartphones Among Patients With Cardiac Implantable Electronic Devices

NCT01819896

Sponsor

Deutsches Herzzentrum Muenchen

Status

Completed

Last Update Posted

Feb 13, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Recipients of Implantable Pacemakers or Defibrillators

Interventions

Pacemaker and defibrillator

Countries

Germany

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

Feb 2013

Primary Completion Date

Oct 2013Actual

Completion Date

Jan 2015Actual

First Submitted Date

Feb 28, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Mar 28, 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 12, 2015

Last Update Posted Date

Feb 13, 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

Description Module

Brief Summary

Over the past year smartphones have developed from a niche product to a commoditized product and are now squeezing classic mobile phones out of market. According to a survey a quarter of the German population is making use of a smartphone at present.

An interference between smartphones and the functionality of pacemakers or implantable defibrillators is rather unlikely but cannot entirely be excluded. A systematic study regarding a possible interference between smartphones and modern pacemaker- and ICD-system with a better shielding against external influence has not taken place so far. In this study the investigators intend to investigate any interference between different smartphones produced by different manufacturers and diverse cardiovascular implanted electronic 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

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

300Estimated

Label	Type	Description	Intervention Names
pacemakers and defibrillators			Drug: Pacemaker and defibrillator

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker and defibrillator	Drug		pacemakers and defibrillators

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interference of smartphones with cardiac implantable electronic devices	Interference testing will be performed during routine follow-up of pacemakers or defibrillators and potential interference will be recorded by ECG.	acute study (no follow-up)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of an implantable pacemaker or defibrillator

Exclusion Criteria:

Lead malfunction which can not reprogrammed
Battery depletion

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

Recipients of implantable pacemakers or defibrillators

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen		München	Bavaria	80636	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D047548	Defibrillators

Ancestor Terms

ID	Term
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided