Falls and Cardiovascular Events in Pacemaker Patients

Medtronic

Status and phase: Completed; Phase 4

Conditions: Bradycardia

Treatments: Other: Fill out Questionnaire

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037426

CH190609-V1

Details and patient eligibility

About

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

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

Study group

Other group

Description:

Falls before versus after pacemaker implant

Treatment:

Other: Fill out Questionnaire