Falls and Cardiovascular Events in Pacemaker Patients

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037426
• Other study ID #: CH190609-V1
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2009
• Last updated: September 4, 2017
• Start date: August 2009
• Est. completion date: January 2014

Study information

• Verified date: September 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Sick Sinus Syndrome

Intervention

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

Locations

Country	Name	City	State
Switzerland	Zuger Kantonsspital	Baar
Switzerland	University Hospital Basel	Basel
Switzerland	SG Spitalregion RWS	Kanton Sankt Gallen
Switzerland	CHCVS - Hôpital de SION	Sion
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Luzerner Kantonsspital	Sursee
Switzerland	Stadtspital Waid	Zurich
Switzerland	USZ - University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Brenner R, Ammann P, Yoon SI, Christen S, Hellermann J, Girod G, Knaus U, Duru F, Krasniqi N, Ramsay D, Sticherling C, Lippuner K, Kühne 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker		2 years
Secondary	fracture risk profile and 10-yr fracture risk based on the WHO FRAX index		2 years
Secondary	fall rate of recurrent fallers		2 years
Secondary	fracture rate		2 years
Secondary	combined CV and mortality endpoint		2 years
Secondary	any of the individual cardiovascular endpoints		2 years
Secondary	mortality		2 years