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Back To Vidyya European Study To Evaluate Hospitalization, Survival Of Patients Who Get Cardiac Resynchronization And Optimal Drug Therapy For Heart Failure

18-Month, 800-Patient Study First Follow-Up In Europe To Measure Device/Drug Combination Treatment

To further support the possibility that therapy to resynchronize the failing heart's beating action may lengthen life span, in addition to keeping patients more healthy, Medtronic, Inc., today announced enrollment of the first patients in a major new European study with implications for thousands of the world's heart failure patients.

The study, called the Cardiac Resynchronization - Heart Failure (CARE-HF) trial, is the first 18-month study in Europe to evaluate 800 patients for the effect of the new device-based therapy on hospitalization, death and quality of life. Positive results would add significant validity to the combination of device-based therapies with drug regimens in the treatment of heart failure.

Heart failure affects more than 22.5 million persons worldwide, including six million Europeans, with approximately 500,000 new patients diagnosed each year. It is a major cost and quality-of-life issue for people with the disease and is characterized by frequent hospital admissions.

Physicians participating in the CARE-HF trial will study whether patients whose heart conditions do not require device therapy will benefit from a new, specialized implantable resynchronization device intended to restore synchronized beating to the left and right sides of the failing heart for more efficient pumping action. The new study asks: What is the added effect, if any, of cardiac resynchronization therapy on the life span and health of heart failure patients already receiving diuretics and optimal medical therapy?

The CARE-HF study, a randomized controlled trial, is to take place at approximately 100 heart centers in 12 European countries. Its 800 patients -- 400 receiving cardiac resynchronization associated with optimal pharmacological therapy and 400 who receive optimal pharmacological therapy only -- will be in New York Heart Association Classes III or IV, indicating that their chronic heart failure has dramatically progressed. Patients will be followed for at least 18 months.

The first patients to be enrolled in the CARE-HF trial on January 9, 2001, were a 70-year-old female at the Centre Hospitalier Universitaire in Rennes, France, and a 50-year-old male at the University Hospital Skejby in Aarhus, Denmark. Both suffer from advanced heart failure (New York Heart Association Classes III or IV) with ventricular conduction delays and are currently on multiple medications such as diuretics, ACE inhibitors and beta-blockers.

A steering committee of cardiologists are leading the trial, headed by Chairman Prof. J.G.F. Cleland, of Kingston-upon-Hull, U.K. The committee includes Prof. Jean Claude Daubert of Rennes, France; Prof. Erland Erdman of Cologne, Germany; Dr. Daniel Gras, Paris, France; Prof. Lukas Kappenberger of Lausanne, Switzerland; Prof. Werner Klein, Graz, Austria; Prof. Luigi Tavazzi, Pavia, Italy, and Prof. Nick Freemantle, Birmingham, U.K.

The committee has noted that previous and concurrent studies are suggesting the efficacy of cardiac resynchronization but that a direct comparison to a combination drug/device therapy is essential before physicians establish its place in the long-term care continuum. "Despite advances in drug treatment, many patients with heart failure still have severe symptoms," said Prof. Cleland. "We feel that a successful, positive conclusion to this landmark study will help us quantify the effect of resynchronization and allow us to research it in concert with pharmaceuticals in affecting disease progression. We know the effectiveness of drugs is highly variable and patient-specific; now we must ascertain whether device-based therapies can play the role we think they can."

Four hundred patients randomized to cardiac resynchronization therapy are to receive one of two implantable systems used with Attain(TM) left-heart leads:

  • -- Implanted under the skin in the chest area, the cardiac resynchronization system delivers electrical impulses via two insulated wires threaded through veins inside the right atrium (upper chamber) and ventricle (lower chamber). A third wire is maneuvered through a vein on the heart's surface that leads to the left ventricle. The device was commercially released to the European market in 1998 and is currently undergoing clinical evaluation in the United States.
  • -- The new implantable cardiac resynchronization system designed to allow physicians to program and control the beating action of the right and left sides of the heart independently. It also includes heart failure-specific diagnostic capabilities intended to monitor a patient's heart rate trends and activity levels. Clinical evaluation is under way in Europe.

Data from CARE-HF and other European studies involving Medtronic cardiac resynchronization therapies will complement those now being collected in the U.S./Canada Multi-center InSync Randomized Clinical Evaluation (MIRACLE) study which is also evaluating a comparable group of about 300 patients at about 45 U.S. and Canadian centers.

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Editor: Susan K. Boyer, RN
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