Setrox JS Master Study

Biotronik

Status: Completed

Conditions: Cardiac Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01487941

56

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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