Falls and Cardiovascular Events in Pacemaker Patients

Phase 4

Completed

• Conditions: Bradycardia
• Interventions: Other: Fill out Questionnaire

• Registration Number: NCT01037426
• Lead Sponsor: Medtronic Bakken Research Center

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Fill out Questionnaire	Falls before versus after pacemaker implant

Primary Outcome Measures

Name	Time	Method
number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker	2 years

Secondary Outcome Measures

Name	Time	Method
combined CV and mortality endpoint	2 years
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
any of the individual cardiovascular endpoints	2 years
mortality	2 years

Trial Locations

Locations (8)

Luzerner Kantonsspital; 🇨🇭 Sursee, Switzerland

Stadtspital Waid; 🇨🇭 Zurich, Switzerland

Zuger Kantonsspital; 🇨🇭 Baar, Switzerland

SG Spitalregion RWS; 🇨🇭 Kanton Sankt Gallen, Switzerland

USZ - University Hospital Zurich; 🇨🇭 Zurich, Switzerland

CHCVS - Hôpital de SION; 🇨🇭 Sion, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland