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Falls and Cardiovascular Events in Pacemaker Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037426
First Posted: December 23, 2009
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  Purpose
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.

Condition Intervention Phase
Bradycardia Other: Fill out Questionnaire Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Patients were their own control and number of falls was compared in the year before and after Pacemaker implant
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • fracture risk profile and 10-yr fracture risk based on the WHO FRAX index [ Time Frame: 2 years ]
  • fall rate of recurrent fallers [ Time Frame: 2 years ]
  • fracture rate [ Time Frame: 2 years ]
  • combined CV and mortality endpoint [ Time Frame: 2 years ]
  • any of the individual cardiovascular endpoints [ Time Frame: 2 years ]
  • mortality [ Time Frame: 2 years ]

Enrollment: 87
Study Start Date: August 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study group
Falls before versus after pacemaker implant
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037426


Locations
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, Switzerland
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Michael Kuehne, Dr. med. University Hospital, Basel, Switzerland
Study Director: Ray Moser, PhD Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland
  More Information

Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01037426     History of Changes
Other Study ID Numbers: CH190609-V1
First Submitted: August 6, 2009
First Posted: December 23, 2009
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no plan

Keywords provided by Medtronic Bakken Research Center:
SND Sinus Node Disease
Falls
Fractures

Additional relevant MeSH terms:
Bradycardia
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block