Falls and Cardiovascular Events in Pacemaker Patients
This study is currently recruiting participants.
Verified April 2013 by Medtronic Bakken Research Center
Sponsor:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01037426
First received: August 6, 2009
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Bradycardia |
Other: Fill out Questionnaire |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Falls and Cardiovascular Events in Elderly Patients With Sinus Node Disease Treated With a MVPTM Pacemaker According to the ESC 2007 Guidelines |
Resource links provided by NLM:
Further study details as provided by Medtronic Bakken Research Center:
Primary Outcome Measures:
- number of falls in SND patients during one year before versus one year after implantation of a MVPTM pacemaker [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- fracture risk profile and 10-yr fracture risk based on the WHO FRAX index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- fall rate of recurrent fallers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- fracture rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- combined CV and mortality endpoint [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- any of the individual cardiovascular endpoints [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: Fill out Questionnaire
- 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
Questionnaire at time of Implantation and 12 months after pacemaker implantation to collect
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037426
Locations
| Switzerland | |
| Zuger Kantonsspital | Recruiting |
| Baar, Switzerland | |
| Contact: David Ramsay, Dr. med. david.ramsay@zgks.ch | |
| Principal Investigator: David Ramsay, Dr. med. | |
| University Hospital Basel | Recruiting |
| Basel, Switzerland | |
| Contact: M Kuehne, Dr. med. mkuehne@uhbs.ch | |
| Principal Investigator: M Kuehne, MD, PhD | |
| SG Spitalregion RWS | Recruiting |
| Kanton Sankt Gallen, Switzerland | |
| Contact: Jens Hellermann, PD Dr. med. Jens.Hellermann@srrws.ch | |
| Principal Investigator: Jens Hellermann, PD Dr. med. | |
| Kantonsspital Liestal | Recruiting |
| Liestal, Switzerland | |
| Contact: Werner Estlinbaum, Dr. med. werner.estlinbaum@ksli.ch | |
| Principal Investigator: Werner Estlinbaum, Dr. med. | |
| CHCVS - Hôpital de SION | Recruiting |
| Sion, Switzerland | |
| Contact: Grégoire Girod, Dr. med. gregoire.girod@rsv-gnw.ch | |
| Principal Investigator: Grégoire Girod, Dr. med. | |
| Kantonsspital St. Gallen | Recruiting |
| St. Gallen, Switzerland | |
| Contact: Peter Ammann, Prof. Dr. med. peter.ammann@kssg.ch | |
| Principal Investigator: P Ammann, MD, PhD | |
| Luzerner Kantonsspital | Recruiting |
| Sursee, Switzerland | |
| Contact: See I Yoon, Dr. med. se-il.yoon@ksl.ch | |
| Principal Investigator: See-I Yoon, Dr. med. | |
| Stadtspital Waid | Recruiting |
| Zurich, Switzerland | |
| Contact: Stefan Christen, Dr. med. stefan.christen@waid.zuerich.ch | |
| Principal Investigator: Stefan Christen, Dr. med. | |
| USZ - University Hospital Zurich | Recruiting |
| Zurich, Switzerland | |
| Contact: Firat Duru, Prof. firat.duru@usz.ch | |
| Principal Investigator: Firat Duru, Prof | |
Sponsors and Collaborators
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 |
More Information
No publications provided
| Responsible Party: | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT01037426 History of Changes |
| Other Study ID Numbers: | CH190609-V1 |
| Study First Received: | August 6, 2009 |
| Last Updated: | April 26, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Medtronic Bakken Research Center:
|
SND Sinus Node Disease Falls Fractures |
Additional relevant MeSH terms:
|
Sick Sinus Syndrome Bradycardia Arrhythmia, Sinus Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Heart Block Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013