Lovelace joins groundbreaking clinical trial focused on heart failure treatment

The Heart Hospital of New Mexico at Lovelace Medical Center has joined a potentially groundbreaking clinical trial addressing heart failure.

The CORCINCH-HF study, which the Lovelace Health System hospital is the first in the state to join, is tracking the safety and efficacy of California-based Ancora Heart’s AccuCinch ventricular restoration system. The device aims to improve the structure and function of the muscular organ and increase life expectancy. Lovelace medical staff surgically inserted the device into the first New Mexico patient on Tuesday.

Dr. Mark Bieniarz, an interventional cardiologist with the New Mexico Heart Institute and Lovelace Medical Group and the trial’s principal investigator, told the Journal the procedure lasted four hours.

“It was perfect,” he said.

The device is placed into a patient’s heart, with anchors underneath the mitral valve and spacers that cinch one part of the organ to improve the function in other areas, Bieniarz said.

“What we’ve seen in the pilot trial … is the rest of the heart starts responding,” Bieniarz said. “People’s hearts not only shrink down — their symptoms improve.”

Bieniarz said the trial looks to enroll some 450 patients, noting that about half of those slots have been filled. So far, 100 devices have been surgically inserted into patients across the globe. Lovelace has looked at three additional New Mexico patients who could be a good fit for the trial.

“The trial can only be done with people whose heart muscle is a certain thickness,” Bieniarz said. With the other prospects, “we are waiting on CAT scans to assess the size of the heart muscle.”

Lovelace has a long history of clinical trials associated with the heart, ranging from drug to device trials, Bieniarz said. That includes the STEMI-DTU trial, which placed a pump in the heart to treat people experiencing heart attacks.

“We were the second-highest enroller in the United States, third-highest enroller in the world,” he said. “It was a remarkable trial.”

But drug trials in recent years have become more common for treating heart failure in particular, Bieniarz said. That’s part of what made joining the CORCINCH-HF study appealing.

“People are facing a really hard decision when they are in end-stage heart failure — whether they’re going to have one of these advanced therapies like … a heart transplant or just going toward supportive care,” Bieniarz said. “This is going to fit a niche between having to make that hard decision and say, ‘Hey, there’s an involved device that may very well help me.’”