Falls and Cardiovascular Events in Pacemaker Patients

Study Overview
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Brief Summary
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The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.

Detailed Description
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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.

Official Title
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Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines

Conditions
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Bradycardia

Intervention / Treatment
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* Other: Fill out Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Patients were their own control and number of falls was compared in the year before and after Pacemaker implant
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study group<br>Falls before versus after pacemaker implant | Other: Fill out Questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fracture risk profile and 10-yr fracture risk based on the WHO FRAX index |  | 2 years | 
| fall rate of recurrent fallers |  | 2 years | 
| fracture rate |  | 2 years | 
| combined CV and mortality endpoint |  | 2 years | 
| any of the individual cardiovascular endpoints |  | 2 years | 
| mortality |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SND Sinus Node Disease, Falls, Fractures