University of Michigan recruiting advanced heart failure patients for new clinical trial

Momentum III is largest trial of its kind to study HeartMate III™ device

ANN ARBOR, Mich. – The University of Michigan Frankel Cardiovascular Center is one of 60 select hospitals in the country recruiting advanced-stage heart failure patients for a new clinical trial.

The MOMENTUM III clinical trial is designed to evaluate the performance and safety of the new left ventricular assist device HeartMate III™ – an implantable device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.

To be eligible for this study, patients must have advanced heart failure that is not responding to current treatment.

Enrolling more than 1,000 patients, the trial is the largest ever of its kind and the U-M is currently the only hospital in Michigan to offer the new therapy in the trial setting.

Francis D. Pagani
Francis D. Pagani, M.D., Ph.D.

“Advanced heart failure sufferers know that their disease is progressive, and that is why it is so important for the University of Michigan to evaluate the most cutting-edge treatment options to restore these patients to a better quality of life,” says cardiac surgeon Francis Pagani, M.D., Ph.D., surgical director of the U-M Heart Transplant Program and its Center for Circulatory Support.

Nearly 6 million people are diagnosed with congestive heart failure in the United States. Of these more than 250,000 are advanced cases with an annual death rate of 80 percent.

For most patients, either a past heart attack or certain conditions such as hypertension, heart muscle diseases, abnormal heart valves, or diabetes has led to heart failure.

Researchers will evaluate the Thoratec® HeartMate III for use as long-term support for patients who are not candidates for a heart transplant. It will also be evaluated for short-term support options for patients waiting for a heart transplant.

The goals of VAD therapy include:

  • Survival: Provide a survival benefit over non-device therapies
  • Quality of life: Allow patients to live a fulfilling life
  • Active patient lifestyle: Facilitate life at home, potentially providing significant psychological and social benefits to the patient as well as cost savings for both the patient and the hospital.

“While the number of patients being diagnosed with advanced heart failure continues to rise, the number of donor hearts has remained stagnant. For the rest, LVADs are an important alternative,” Pagani says. “We’re proud to be one of the first to assess the HeartMate III and look forward to making it available to Michigan patients.”

Clinicians and researchers at the U-M Center for Circulatory Support have provided leadership in the clinical investigation of most of the implantable circulatory support devices in use today and have implanted more than 500 devices.

For more information about the MOMENTUM III Clinical Trial, please call the study coordinator at (888) 286-4420, email cvcvolunteer@med.umich.edu or visit or visit UMClinicalStudies.org.

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US: Caution:

Investigational Device: Limited by Federal United States law to investigational use.

 

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