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The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Other | Falls before versus after pacemaker implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fill out Questionnaire | Other | Questionnaire at time of Implantation and 12 months after pacemaker implantation to collect
|
| Measure | Description | Time Frame |
|---|---|---|
| number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kuehne, Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Ray Moser, PhD | Medtronic (Schweiz) AG - Münchenbuchsee - Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuger Kantonsspital | Baar | Switzerland | ||||
| University Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27702858 | Background | 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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there is no plan
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Patients were their own control and number of falls was compared in the year before and after Pacemaker implant
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|
| 2 years |
| combined CV and mortality endpoint | 2 years |
| any of the individual cardiovascular endpoints | 2 years |
| mortality | 2 years |
| Basel |
| Switzerland |
| SG Spitalregion RWS | Kanton Sankt Gallen | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| CHCVS - Hôpital de SION | Sion | Switzerland |
| Luzerner Kantonsspital | Sursee | Switzerland |
| Stadtspital Waid | Zurich | Switzerland |
| USZ - University Hospital Zurich | Zurich | Switzerland |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |