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InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00271232
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : December 21, 2007
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:

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 or disease Intervention/treatment
Heart Failure Device: Cardiac resynchronization therapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
Study Start Date : March 2003
Estimated Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. To evaluate the safety and effectiveness of the InSync III Marquis Model 7279 in heart failure patients who were indicated for an ICD

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271232

  Show 34 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00271232     History of Changes
Other Study ID Numbers: 199
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure, Cardiac Resynchronization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases