Setrox JS Master Study | NCT01487941

Studies
Setrox JS Master Study

NCT01487941

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Nov 20, 2014Estimated

Enrollment

66Actual

Phase

Not provided

Conditions

Cardiac Disease

Interventions

Not provided

Countries

Czechia

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 2014

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

Dec 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Oct 2014Actual

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 8, 2011Estimated

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 19, 2014

Last Update Posted Date

Nov 20, 2014Estimated

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

Not provided

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

66Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serious Adverse Device Effect rate		6 months
Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the indications for pacemaker therapy
Available for follow-up visits on a regular basis at the investigational site
Contractual capability and ability to consent
Age ≥18 years

Exclusion Criteria:

Meet one or more of the contraindications for pacemaker therapy
Permanent atrial fibrillation
Have a life expectancy of less than six months
Cardiac surgery in the next six months
Enrolled in another cardiac clinical investigation
Have other medical devices that may interact with the implanted pacemaker
Pregnant and breast-feeding women

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

Patients with pacemaker indication

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SV. Anny Clinic Brno		Brno		656 91	Czechia