Cardiac Pacemaker Syndrome
Conditions
Keywords
leads, pacemaker, efficacy, safety
Brief summary
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
Detailed description
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.
Interventions
DEVICEPacemaker therapy
Implantation of the SIELLO pacemaker leads
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Meet the indications for pacemaker therapy * Understand the nature of the procedure * Give informed consent * Able to complete all testing required by the clinical protocol * Available for follow-up visits on a regular basis at the investigational site
Exclusion criteria
* Meet none of the pacemaker indications * Meet one or more of the contraindications * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complication free rate of all SIELLO leads | 3 month follow-up visits |
| Ventricular threshold of SIELLO T (passive fixation) | 3 month follow-up visits |
| Atrial threshold of SIELLO S (active fixation) | 3 month follow-up visits |
Countries
Germany
Outcome results
None listed