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| Sponsor: | Medtronic Cardiac Rhythm Disease Management |
|---|---|
| Collaborator: |
Medtronic |
| Information provided by: | Medtronic Cardiac Rhythm Disease Management |
| ClinicalTrials.gov Identifier: | NCT00281099 |
Purpose
The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.
| Condition | Intervention |
|---|---|
|
Heart Disease |
Device: ICD (Implantable Cardioverter Defibrillator) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial) |
Echocardiogram measures for each endpoint were obtained at multiple time points.
LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.
LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%.
Echocardiogram measures for each endpoint were obtained at multiple time points.
LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis.
Persistent AF was defined as any of the following:
Clinically Important AF was defined as more than 20 hours of AT/AF in a single day
Minnesota Living with Heart Failure Questionnaire ("MLWHFQ") and Kansas City Cardiomyopathy Questionnaire ("KCCQ") Quality of Life("QOL") Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.
Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)
| Enrollment: | 1031 |
| Study Start Date: | October 2004 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: VVI 40 pacing
Backup ventricular pacing (VVI) at 40 beats per minute
|
Device: ICD (Implantable Cardioverter Defibrillator)
VVI 40 vs. MVP
Other Names:
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Active Comparator: MVP pacing
Managed ventricular pacing (MVP) at 60 beats per minute
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Device: ICD (Implantable Cardioverter Defibrillator)
VVI 40 vs. MVP
Other Names:
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Recent research supports the hypothesis that reducing the amount of pacing in the lower right chamber of the heart may prevent the progression of congestive heart failure (CHF) in some implantable cardioverter defibrillator (ICD) patients. CHF refers to symptoms (shortness of breath, fatigue, fluid overload) caused by decreased pumping action of the heart muscle. The ICD can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). Both settings allow the heart to beat more naturally using its own electrical signals. Two device settings will be compared. Managed ventricular pacing (MVP) will allow the ICD to use both wires only as necessary. This setting allows the ICD to send electrical signals to the top and bottom chambers of the heart if needed. The other setting, ventricular pacing (VVI) will allow the ICD to operate the bottom chamber of the heart if it is needed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 73 Study Locations| Principal Investigator: | Michael O Sweeney | Brigham and Women's Hospital |
More Information
| Responsible Party: | Steve Erickson, Principal Clinical Trial Leader, Medtronic CRDM |
| ClinicalTrials.gov Identifier: | NCT00281099 History of Changes |
| Other Study ID Numbers: | 240 |
| Study First Received: | January 20, 2006 |
| Results First Received: | June 30, 2009 |
| Last Updated: | July 30, 2010 |
| Health Authority: | United States: Institutional Review Board; Canada: Health Canada; European Union: European Medicines Agency |
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ICD Pacing Heart Failure |
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Heart Diseases Cardiovascular Diseases |