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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which the Setrox JS lead improves cardiac pacing outcomes in patients with arrhythmias?
How does the J-shaped screw design of the Setrox JS lead compare to traditional pacing leads in terms of long-term efficacy and safety for cardiac disease management?
What biomarkers are associated with optimal patient selection for implantation of the Setrox JS lead in heart failure or bradycardia cases?
What adverse events have been reported with the Setrox JS lead and how do they compare to standard-of-care pacemaker leads in clinical practice?
Are there any combination therapies or alternative pacemaker technologies that demonstrate enhanced therapeutic outcomes compared to the Setrox JS lead in treating cardiac conduction disorders?
Trial Locations
- Locations (1)
SV. Anny Clinic Brno
🇨🇿Brno, Czech Republic
SV. Anny Clinic Brno🇨🇿Brno, Czech Republic