NCT01037426

Falls and Cardiovascular Events in Pacemaker Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2009-08-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2009-12-23
• Last updated: 2025-07-03

Locations

8 sites across 1 country: Switzerland