Setrox JS Master Study

Efficacy and Safety of the Setrox JS Lead (J=J-shaped, S=Screw)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01487941

Enrollment

Registered

2011-12-08

Start date

2011-12-31

Completion date

2014-10-31

Last updated

2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Brief summary

The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead Setrox JS.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Czechia

Outcome results