Falls and Cardiovascular Events in Pacemaker Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01037426
First received: August 6, 2009
Last updated: April 3, 2014
Last verified: April 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 86
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
No Intervention: Study group 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01037426     History of Changes
Other Study ID Numbers: CH190609-V1
Study First Received: August 6, 2009
Last Updated: April 3, 2014
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014