Linox Smart S DX PME/Master Study | NCT01090401

Studies
Linox Smart S DX PME/Master Study

NCT01090401

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Nov 16, 2011Estimated

Enrollment

116Actual

Phase

Phase 4

Conditions

ICD Indication

Interventions

Linox smart S DX

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

Nov 2011

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

Mar 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Oct 2011Actual

First Submitted Date

Mar 18, 2010

First Submission Date that Met QC Criteria

Mar 18, 2010

First Posted Date

Mar 22, 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

Nov 15, 2011

Last Update Posted Date

Nov 16, 2011Estimated

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

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Linox smart S DX lead	Experimental		Device: Linox smart S DX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linox smart S DX	Device	ICD lead	Patients with Linox smart S DX lead

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of atrial adequate sensing		6 months

Secondary Outcomes

Measure	Description	Time Frame
Linox smart S DX related complication-free rate		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with standard ICD indication
Be available for follow-up visits on a regular basis at an approved investigational center

Exclusion Criteria:

Patients with standard ICD contra-indication
Patients with permanent atrial fibrillation
Have a life expectancy of less than six months
Are expecting to receive cardiac surgery within 6 months after enrollment
Age < 18 years
Not enrolled in another cardiac clinical investigation

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University Hospital Benjamin Franklin		Berlin		12200	Germany