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

Status

Completed

Conditions

Intervention / Treatment

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

  • Switzerland
      • 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
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

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

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

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.

General Publications

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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