Clinical Study to analyse safety, effectiveness and efficiency of new EVIA pacemaker family during routine pacemaker follow up after implantation.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Bradyarrhythmia
- Registration Number
- CTRI/2011/05/001746
- Lead Sponsor
- BIOTRONIK SE Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1500
Inclusion Criteria
1. The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent.
2. EVIA pacemaker implantation performed within 6 weeks prior to enrollment.
Exclusion Criteria
1. Age less than 18 years.
2. Participation in another clinical study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of (Serious) pacemaker - related Adverse Device EffectsTimepoint: 12 +/- 2 Months
- Secondary Outcome Measures
Name Time Method