HonorHealth Research Institute clinical trial helps secure FDA approval of revolutionary new pacemaker

World’s first dual chamber leadless pacemaker successfully implanted in 22 HonorHealth patients, stimulating two heart chambers without using wires

SCOTTSDALE, Ariz. — Sept. 19, 2023 — HonorHealth Research Institute is ushering in a new era of heart pacemakers for patients with abnormal or slow heart rhythms by helping secure FDA approval of the world’s first dual chamber leadless pacemaker.

“What a difference this makes for our patients!” said Dr. Rahul Doshi, an electrophysiologist in the research institute’s Cardiovascular Research Division, and one of the authors of a study detailing the clinical trial of the new pacemaker system, which was published recently in The New England Journal of Medicine.


“We’re able to get this technology that is brand new and that provides real benefit to our patients,” said Dr. Doshi, the principal investigator of the clinical trial at HonorHealth Research Institute, which successfully implanted the revolutionary device — the world’s first dual chamber leadless pacemaker — in 22  patients, including some of the first of the more than 300 clinical trial participants worldwide.

“You can imagine that for these patients it’s absolutely life changing,” said Dr. Doshi, noting the nearly half-century evolution of pacemakers: from the large, wired devices that once required open-heart surgery, to the sleek new AVEIR DR dual chamber leadless pacemaker system, in which two cylinders, each smaller than an AAA battery, are placed using a catheter through a large leg vein directly into the upper and the lower right chambers of the heart.

Study patient: ‘I felt so much better’

Barbara Giovan, 73, a retired hospital laboratories administrator, had two open-heart surgeries over the past decade to repair and replace valves in her heart.

“I was short of breath. My heart rate was low,” said Giovan, who was excited to qualify for the research institute’s pacemaker clinical trial: “For vanity reasons I thought it’s much better to have the pacemakers in my heart where I can’t see them.”

After Dr. Doshi implanted the pacemakers in April 2022, Giovan said, “I felt so much better. I have so much more energy. I play golf 3 or 4 times a week. I exercise. I walk. I feel totally fine. I’m not inhibited in any way, and I’m looking forward to having a good long life.”

How system makes the heart work

The two Aveir cylinders communicate wirelessly, providing a steady electrical pulse that first stimulates the heart’s upper right atrium, which loads blood into the lower right ventricle, and then stimulates the lower right ventricle to pump the blood to the lungs — a process known as “atrioventricular synchrony.” (And, in sync with the right-side chambers, the heart’s left atrium and powerful left ventricle pump the oxygenated blood from the lungs to the rest of the body.)

“A dual-chamber leadless pacemaker system … would make leadless pacemaker therapy a treatment option for a wider range of indications,” according to the study published June 22 in NEJM.

The AVEIR system, manufactured by Abbott Laboratories, based in Abbott Park, Ill., was approved by the FDA on June 29, 2023, and Giovan said she was “honored” to have been among the 300 clinical trial participants who helped get it approved.

HonorHealth one of few sites nationwide

Dr. Doshi said HonorHealth Research Institute will be one of a few sites in the U.S. that will initially offer the newly approved system commercially to patients outside the clinical trial.

Continuing a history of “phenomenal evolution driven by technology,” Dr. Doshi said, dual chamber pacemakers with leads have been in use for nearly three decades. But their wire leads were potentially problematic; subject to breakage and able to cause scarring in the veins, heart valves and heart muscle, and create risk of trauma that may cause bleeding in the lungs and heart. Pockets are created under the skin to hold the generator, which can also lead to infections, skin erosion, and unwanted scarring. Plus, the wires are subject to being infected, requiring their removal, which Dr. Doshi described as “a high-risk procedure.”

In recent years, HonorHealth Research Institute also pioneered single chamber leadless pacemakers, but as noted in the NEJM paper, “Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony.”

The 300 patients in the clinical trial were treated at 58 sites in the U.S.; 82 sites worldwide. Participants were divided among:

  • 190 with sinus-node disfunction, in which the sinus node of the right atrium — the body’s natural pacemaker — no longer provides a proper electrical signal.
  • 100 with AV dysfunction, also known as heart block, in which the electrical signal from the right atrium fails to properly coordinate with the right ventricle.

“This new system now provides a solution for the vast majority of patients who need pacemakers,” said Dr. Doshi, adding, “Dual chamber leadless pacing is going to revolutionize leadless pacing, and I believe it could actually take over the entire pacing world.”

The new system’s devices are fully contained, he explains, including the ability to sense and coordinate the cardiac rhythm, delivering a pacing impulse directly to the myocardium, the heart muscle, in step with the body’s needs.

Also contributing to the NEJM study, “A Dual Chamber Leadless Pacemaker,” were: Amsterdam University Medical Centers; Icahn School of Medicine at Mount Sinai; Weill Cornell Medicine–New York Presbyterian Hospital; Foothills Medical Centre; Centre Hospitalier Régional Universitaire; Texas Cardiac Arrhythmia Institute; Azienda Ospedaliero–Universitaria Pisana; Tokyo Women’s Medical University; Deutsches Herzzentrum der Charité; Na Homolce Hospital; Huntington Memorial Hospital; Abbott; and the Cleveland Clinic.

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 About the HonorHealth Research Institute

HonorHealth Research Institute is an international destination that is at the forefront of providing patients with a better quality of life through its clinical trials and innovative treatment options. Headquartered in Scottsdale, Arizona, the institute’s team of physicians and researchers collaborate with experts from across the nation to offer life-changing therapies, drugs and devices. At HonorHealth Research Institute, patients have access to tomorrow’s health innovations, today. Learn more at: HonorHealth.com/research.


Posted in AZBio News.