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Heart study implants hope

September 06 , 2017

Heart Center Research is seeking patients with decreased heart pumping function, diabetes and a history of heart attacks to participate in a worldwide clinical trial of a new implantable defibrillator device.

The MADIT S-ICD study will evaluate whether a defibrillator implanted under the skin near a patient’s rib cage is effective at preventing sudden cardiac death in certain patients with a history of heart attacks, decreased heart pumping function and diabetes. MADIT stands for Multicenter Automatic Defibrillator Implantation Trial; S-ICD stands for Subcutaneous Implantable Cardioverter-Defibrillator.

On June 9, Lynchburg, Tenn. resident Stephen Cray became just the second person in the world to receive the device as part of the new study. Cray, who has Type 2 diabetes and survived a heart attack in July 2016, said he signed up for the study because fear of a having another cardiac event was “making me sicker and sicker.” He had the defibrillator surgically implanted on his 70th birthday. 

“It’s really given me a different frame of mind,” Cray said about a week after the procedure. “I’m not thinking about and worrying about my heart as much.”

Jay dinerman, MD, a Heart Center electrophysiologist and the study’s principal investigator, performed the outpatient procedure at Huntsville Hospital. 

“Participating in research studies allows us to offer potentially beneficial treatments to our patients that are not otherwise available,” said Dr. Dinerman. “The knowledge gained not only helps those subjects enrolled in the study but also other patients who suffer from similar problems.”

Underwritten by Boston Scientific, a medical device company, the defibrillator trial is open to patients with diabetes who have had a heart attack and whose heart pumping function is moderately decreased.

Previous studies showed that implanted defibrillators can improve quality of life and decrease mortality for cardiac patients with severely diminished heart pumping. The device delivers an electric shock that can convert life threatening cardiac rhythms into normal heart rhythms.

The current study is the first to track the success of defibrillators on heart patients with diabetes.

Dr. Dinerman said 1,800 patients will be enrolled in the study worldwide atapproximately 100 clinical centers. Two-thirds of the patients will receive the defibrillator implant; the rest will get standard medical care. The two groups will be compared through the end of the study in early 2022.

The defibrillator study is one of several exciting new happenings around Huntsville Hospital’s nationally recognized cardiovascular program. Huntsville Hospital Heart Center also recently opened a new location in Athens, welcomed cardiologist chris roth, MD, to its medical staff, and launched a national search to attract three more cardiologists to the area, including a heart failure specialist.

“We’re working hard to meet the needs of the community,” said Heart Center President Josh Hewiett.

If you think you meet the criteria for the MADIT S-ICD trial and would like to learn more, please contact Heart Center Research at (256) 519-8472.