- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037426
Falls and Cardiovascular Events in Pacemaker Patients
September 4, 2017 updated by: Medtronic Bakken Research Center
Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
Study Overview
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
Interventional
Enrollment (Actual)
87
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Baar, Switzerland
- Zuger Kantonsspital
-
Basel, Switzerland
- University Hospital Basel
-
Kanton Sankt Gallen, Switzerland
- SG Spitalregion RWS
-
Sion, Switzerland
- CHCVS - Hôpital de Sion
-
St. Gallen, Switzerland
- Kantonsspital St. Gallen
-
Sursee, Switzerland
- Luzerner Kantonsspital
-
Zurich, Switzerland
- Stadtspital Waid
-
Zurich, Switzerland
- USZ - University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Study group
Falls before versus after pacemaker implant
|
Questionnaire at time of Implantation and 12 months after pacemaker implantation to collect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fracture risk profile and 10-yr fracture risk based on the WHO FRAX index
Time Frame: 2 years
|
2 years
|
fall rate of recurrent fallers
Time Frame: 2 years
|
2 years
|
fracture rate
Time Frame: 2 years
|
2 years
|
combined CV and mortality endpoint
Time Frame: 2 years
|
2 years
|
any of the individual cardiovascular endpoints
Time Frame: 2 years
|
2 years
|
mortality
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Kuehne, Dr. med., University Hospital, Basel, Switzerland
- Study Director: Ray Moser, PhD, Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
August 6, 2009
First Submitted That Met QC Criteria
December 22, 2009
First Posted (Estimate)
December 23, 2009
Study Record Updates
Last Update Posted (Actual)
September 7, 2017
Last Update Submitted That Met QC Criteria
September 4, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH190609-V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
there is no plan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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