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Falls and Cardiovascular Events in Pacemaker Patients

Primary Purpose

Bradycardia

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
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Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradycardia focused on measuring SND Sinus Node Disease, Falls, Fractures

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zuger Kantonsspital
  • University Hospital Basel
  • SG Spitalregion RWS
  • CHCVS - Hôpital de SION
  • Kantonsspital St. Gallen
  • Luzerner Kantonsspital
  • Stadtspital Waid
  • USZ - University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study group

Arm Description

Falls before versus after pacemaker implant

Outcomes

Primary Outcome Measures

number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker

Secondary Outcome Measures

fracture risk profile and 10-yr fracture risk based on the WHO FRAX index
fall rate of recurrent fallers
fracture rate
combined CV and mortality endpoint
any of the individual cardiovascular endpoints
mortality

Full Information

First Posted
August 6, 2009
Last Updated
September 4, 2017
Sponsor
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01037426
Brief Title
Falls and Cardiovascular Events in Pacemaker Patients
Official Title
Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
SND Sinus Node Disease, Falls, Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Other
Arm Description
Falls before versus after pacemaker implant
Intervention Type
Other
Intervention Name(s)
Fill out Questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
fracture risk profile and 10-yr fracture risk based on the WHO FRAX index
Time Frame
2 years
Title
fall rate of recurrent fallers
Time Frame
2 years
Title
fracture rate
Time Frame
2 years
Title
combined CV and mortality endpoint
Time Frame
2 years
Title
any of the individual cardiovascular endpoints
Time Frame
2 years
Title
mortality
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kuehne, Dr. med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ray Moser, PhD
Organizational Affiliation
Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Zuger Kantonsspital
City
Baar
Country
Switzerland
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
SG Spitalregion RWS
City
Kanton Sankt Gallen
Country
Switzerland
Facility Name
CHCVS - Hôpital de SION
City
Sion
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Sursee
Country
Switzerland
Facility Name
Stadtspital Waid
City
Zurich
Country
Switzerland
Facility Name
USZ - University Hospital Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan
Citations:
PubMed Identifier
27702858
Citation
Brenner R, Ammann P, Yoon SI, Christen S, Hellermann J, Girod G, Knaus U, Duru F, Krasniqi N, Ramsay D, Sticherling C, Lippuner K, Kuhne M. Reduction of falls and fractures after permanent pacemaker implantation in elderly patients with sinus node dysfunction. Europace. 2017 Jul 1;19(7):1220-1226. doi: 10.1093/europace/euw156.
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Falls and Cardiovascular Events in Pacemaker Patients

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