Falls and Cardiovascular Events in Pacemaker Patients

This study is currently recruiting participants.

Verified April 2013 by Medtronic Bakken Research Center

Sponsor:

Information provided by (Responsible Party):

Medtronic Bakken Research Center

ClinicalTrials.gov Identifier:

NCT01037426

First received: August 6, 2009

Last updated: April 26, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 6, 2009

Last Updated Date

April 26, 2013

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01037426 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fracture risk profile and 10-yr fracture risk based on the WHO FRAX index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
fall rate of recurrent fallers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
fracture rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
combined CV and mortality endpoint [ Time Frame: 2 years ] [ Designated as safety issue: No ]
any of the individual cardiovascular endpoints [ Time Frame: 2 years ] [ Designated as safety issue: No ]
mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Falls and Cardiovascular Events in Pacemaker Patients

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Bradycardia

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01037426

Other Study ID Numbers ^ICMJE

CH190609-V1

Has Data Monitoring Committee

Responsible Party

Medtronic Bakken Research Center

Study Sponsor ^ICMJE

Medtronic Bakken Research Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Michael Kuehne, Dr. med.	University Hospital, Basel, Switzerland
Study Director:	Ray Moser, PhD	Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland

Information Provided By

Medtronic Bakken Research Center

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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