Setrox JS Master Study

Completed

• Conditions: Cardiac Disease

• Registration Number: NCT01487941
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Primary Completion: 2013-02
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

SV. Anny Clinic Brno; 🇨🇿 Brno, Czech Republic