Falls and Cardiovascular Events in Pacemaker Patients

NCT01037426 | Completed Phase 4

• 1 other identifier: CH190609-V1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.

Conditions

Bradycardia

Keywords

SND Sinus Node Disease; Falls; Fractures

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (6)

• fracture risk profile and 10-yr fracture risk based on the WHO FRAX index

  2 years

• fall rate of recurrent fallers

  2 years

• fracture rate

  2 years

• combined CV and mortality endpoint

  2 years

• any of the individual cardiovascular endpoints

  2 years

Study Arms (1)

Study group

OTHER

Falls before versus after pacemaker implant

Other: Fill out Questionnaire

Interventions

Fill out Questionnaire OTHER

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

Study group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (8)

Zuger Kantonsspital

Baar, Switzerland

Location

University Hospital Basel

Basel, Switzerland

Location

SG Spitalregion RWS

Kanton Sankt Gallen, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

CHCVS - Hôpital de SION

Sion, Switzerland

Location

Luzerner Kantonsspital

Sursee, Switzerland

Location

Stadtspital Waid

Zurich, Switzerland

Location

USZ - University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27702858 BACKGROUND

MeSH Terms

Conditions

Bradycardia; Fractures, Bone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Michael Kuehne, Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Ray Moser, PhD

  Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients were their own control and number of falls was compared in the year before and after Pacemaker implant

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: December 23, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 3, 2025

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (8)