InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
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Purpose
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm.
The InSync III Marquis device can change the timing of when the left and right ventricles of the heart are paced to beat. This is called "V to V timing". V to V timing may further improve the pumping function of the heart. The purpose of this study is to determine whether or not this V to V timing feature of the InSync III Marquis system is safe and effective.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Device: Cardiac resynchronization therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System |
- To evaluate the safety and effectiveness of the InSync III Marquis Model 7279 in heart failure patients who were indicated for an ICD
- Rate of oxygen uptake (consumption) measured during exercise, all adverse events, echocardiographic assessments (tests done using ultra sound to examine the health of the heart), and device performance
| Estimated Enrollment: | 238 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | April 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined the need for an implantable cardioverter defibrillator.
Subject is on optimal medical treatment for heart failure.
Subject has reduced left ventricular ejection fraction (LVEF≤35%). (LVEF is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)
Subject who has heart failure which severely limits daily activities (NYHA Class III) or subject who has severe heart failure and should always be resting (NYHA Class IV)
Subject who has a QRS≥130ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (more than 120 ms) suggests that there is a conduction problem (or block) in the ventricles.)
Subjects with a left ventricular end diastolic dimension (LVEDD≥55mm). (The LVEDD is a measurement taken during an echocardiogram that is one indication of the health of the left ventricle.)
Exclusion Criteria:
Subject has unstable chest pain, heart surgery within past 3 months
Subject has liver function tests greater than 3 times normal limits
Subject has chronic (permanent) atrial arrhythmias (fast heart beats in the upper chamber(s) of the heart)
Contacts and Locations
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No publications provided by Medtronic Cardiac Rhythm Disease Management
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00271232 History of Changes |
| Other Study ID Numbers: | 199 |
| Study First Received: | December 28, 2005 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medtronic Cardiac Rhythm Disease Management:
|
Heart Failure, Cardiac Resynchronization |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013