Falls and Cardiovascular Events in Pacemaker Patients

Medtronic Cardiac Rhythm and Heart Failure87 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bradycardia

Interventions

Fill out QuestionnaireOTHER

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (8)

Zuger Kantonsspital

Baar, Switzerland

University Hospital Basel

Basel, Switzerland

SG Spitalregion RWS

Kanton Sankt Gallen, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Outcomes

Primary Outcomes

number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker

Time frame: 2 years

Secondary Outcomes

fracture risk profile and 10-yr fracture risk based on the WHO FRAX index

Time frame: 2 years

fall rate of recurrent fallers

Time frame: 2 years

fracture rate

Time frame: 2 years

combined CV and mortality endpoint

Time frame: 2 years

any of the individual cardiovascular endpoints

Time frame: 2 years

mortality

Time frame: 2 years

Data from ClinicalTrials.gov

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