Bradycardia
Conditions
Keywords
SND Sinus Node Disease, Falls, Fractures
Brief summary
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
Detailed description
The purpose of this study is to compare the number of falls and fractures in Sinus Node Disease (SND) patients before versus after implantation of a MVP (TradeMark) pacemaker. Further the effect of pacing in the MVP (TradeMark) mode in respect of cardiovascular events is going to be analyzed in the same population.
Interventions
Questionnaire at time of Implantation and 12 months after pacemaker implantation to collect * History of falls and fractures during the 12 months before pacemaker implantation * Risk markers for falls based on FRAX risk calculator (age, gender, weight, height, history of previous fracture, family history of hip fracture, current smoking habits, glucocorticosteroid intake, rheumatoid arthritis, secondary osteoporosis, alcohol intake) * History of falls and fractures during the 12 months after pacemaker implantation * Medical and Arrhythmia History * Cardiovascular Events * Cardiovascular Medication * Device programming information
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients were their own control and number of falls was compared in the year before and after Pacemaker implant
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sinus Node Disease (SND) treated with a pacemaker with MVP (TM) mode according to ESC 2007 guidelines (SND as primary indication for pacemaker implant, implant within past two weeks) * Geographic stability and availability for follow-up at the study center for the length of the study * Willingness and Ability to sign Informed Consent
Exclusion criteria
* Age less than 50 years * Impaired cognitive function (such as Alzheimer's disease) * permanent AV Block II and III * Persistent atrial fibrillation * Life expectancy less than two years * Enrollment or intended participation in another clinical trial during the course of this study * Subject is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| fall rate of recurrent fallers | 2 years |
| fracture rate | 2 years |
| fracture risk profile and 10-yr fracture risk based on the WHO FRAX index | 2 years |
| any of the individual cardiovascular endpoints | 2 years |
| mortality | 2 years |
| combined CV and mortality endpoint | 2 years |
Countries
Switzerland
Outcome results
None listed