Clinical trial NCT01037426: Falls and Cardiovascular Events in Pacemaker Patients
Official title: Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bradycardia
Keywords: SND Sinus Node Disease
Falls
Fractures
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 87
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients were their own control and number of falls was compared in the year before and after Pacemaker implant
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker
timeFrame: 2 years
Secondary outcomes:
measure: fracture risk profile and 10-yr fracture risk based on the WHO FRAX index
timeFrame: 2 years
measure: fall rate of recurrent fallers
timeFrame: 2 years
measure: fracture rate
timeFrame: 2 years
measure: combined CV and mortality endpoint
timeFrame: 2 years
measure: any of the individual cardiovascular endpoints
timeFrame: 2 years
measure: mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Baar
country: Switzerland
facility: Zuger Kantonsspital
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Kanton Sankt Gallen
country: Switzerland
facility: SG Spitalregion RWS
city: Sion
country: Switzerland
facility: CHCVS - Hôpital de SION
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Sursee
country: Switzerland
facility: Luzerner Kantonsspital
city: Zurich
country: Switzerland
facility: Stadtspital Waid
city: Zurich
country: Switzerland
facility: USZ - University Hospital Zurich
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Michael Kuehne, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland
name: Ray Moser, PhD
role: STUDY_DIRECTOR
References:
citation: Brenner R, Ammann P, Yoon SI, Christen S, Hellermann J, Girod G, Knaus U, Duru F, Krasniqi N, Ramsay D, Sticherling C, Lippuner K, Kuhne M. Reduction of falls and fractures after permanent pacemaker implantation in elderly patients with sinus node dysfunction. Europace. 2017 Jul 1;19(7):1220-1226. doi: 10.1093/europace/euw156.