BradycardiaPhase 4NCT01037426
Falls and Cardiovascular Events in Pacemaker Patients
A Phase 4 study testing Fill out Questionnaire in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in Switzerland.
Trial summary
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Fill out Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 8 sitesSwitzerland
- Study dates
- Aug 2009to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites
Zuger Kantonsspital
Baar
University Hospital Basel
Basel
SG Spitalregion RWS
Kanton Sankt Gallen
Kantonsspital St. Gallen
Sankt Gallen
CHCVS - Hôpital de SION
Sion
Luzerner Kantonsspital
Sursee
Stadtspital Waid
Zurich
USZ - University Hospital Zurich
Zurich
About this study
Official title: 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.
Read the 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.
- Conditions
- Bradycardia
- Being tested
- Fill out Questionnaire
- Keywords
- SND Sinus Node Disease, Falls, Fractures
- Medical subject headings
- Bradycardia, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill out QuestionnaireOther
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 | Role | What they receive |
|---|---|---|
| Study group | Other | Falls before versus after pacemaker implant Receives: Other: Fill out Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker
Measured: 2 years
Secondary outcomes (6)
fracture risk profile and 10-yr fracture risk based on the WHO FRAX index
Measured: 2 years
fall rate of recurrent fallers
Measured: 2 years
fracture rate
Measured: 2 years
combined CV and mortality endpoint
Measured: 2 years
any of the individual cardiovascular endpoints
Measured: 2 years
mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuehne, Dr. med., Principal investigator, University Hospital, Basel, SwitzerlandRay Moser, PhD, Study director, Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037426
- Sponsor's protocol ID
- CH190609-V1
- Status last verified
- Sep 2017
- First submitted
- 6 Aug 2009
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: there is no plan
Publications
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.
PubMed 27702858
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines
- ClinicalTrials.gov ID
- NCT01037426
- Acronym / sponsor ID
- CH190609-V1
- Conditions
- Bradycardia
- Keywords
- SND Sinus Node Disease, Falls, Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients were their own control and number of falls was compared in the year before and after Pacemaker implant
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Other: Fill out QuestionnaireFalls before versus after pacemaker implant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fill out QuestionnaireQuestionnaire 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 | Other | Study group |
Primary outcome
number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker
Time frame: 2 years
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 27702858Brenner 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.
- Individual participant dataSharing planned: No. there is no plan
Related trials for Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
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RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
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Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kuehne, Dr. med. principal investigator
University Hospital, Basel, Switzerland
Ray Moser, PhD study director
Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fill out Questionnaire in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01037426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.