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Completed

NCT Number: NCT01037426

Falls and Cardiovascular Events in Pacemaker Patients

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

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Fractures, Bone Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zuger Kantonsspital, Baar, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fill out Questionnaire

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

Primary outcomes

  1. 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

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

    Time frame: 2 years

  2. fall rate of recurrent fallers

    Time frame: 2 years

  3. fracture rate

    Time frame: 2 years

  4. combined CV and mortality endpoint

    Time frame: 2 years

  5. any of the individual cardiovascular endpoints

    Time frame: 2 years

  6. mortality

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2009
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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