Falls and Cardiovascular Events in Pacemaker Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Bradycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients were their own control and number of falls was compared in the year before and after Pacemaker implant

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study group

Falls before versus after pacemaker implant

Group Type OTHER

Fill out Questionnaire

Intervention Type OTHER

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

Interventions

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Fill out Questionnaire

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

Intervention Type OTHER

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No