Henry Ford Health has enrolled the first two U.S. patients in the PULSE-LHD study testing pulmonary artery denervation for people who have pulmonary hypertension related to heart disease.
- Procedure type: Pulmonary artery denervation is a minimally invasive catheter-based procedure that targets nerves in the pulmonary artery.
- Study design: PULSE-LHD is a randomized, sham-controlled trial evaluating the safety and efficacy of the investigational treatment approach.
- Prior research: A separate study assessing pulmonary artery denervation in China recently published findings in the New England Journal of Medicine.
Henry Ford Health in Detroit has completed enrollment for the first two U.S. patients who are part of the global PULSE-LHD study. The goal of the study, according to researchers, is to determine if an experimental treatment could expand therapeutic options for people living with PH related to heart disease.
The investigational approach is a minimally invasive procedure called pulmonary artery denervation. Treatment is delivered through a small catheter that is inserted through a blood vessel into the pulmonary artery. The procedure is designed to target nerves surrounding the pulmonary artery that likely contribute to elevated pressures in the lungs. The approach uses an investigational medical device that is not currently approved for commercial use by the U.S. Food and Drug Administration (FDA).
The PULSE-LHD trial will use a randomized, sham-controlled study design to evaluate the safety and efficacy of the treatment approach. Participants will undergo either the pulmonary artery denervation procedure or a comparable procedure without treatment delivery.
The initial procedures were completed by interventional cardiologists Vikas Aggarwal, MD, and Brian O’Neill, MD.
“Clinical trials play a critical role in helping us improve care for future patients,” said Dr. Aggarwal, who is director of pulmonary vascular interventions at Henry Ford Health. “Studies such as the PULSE-LHD helps us evaluate interventional therapies using the highest standards of scientific research while offering eligible patients an opportunity to participate in advancing cardiovascular medicine.”
A separate study that assessed pulmonary artery denervation in China recently published its findings in the New England Journal of Medicine. The paper is titled, “Pulmonary Denervation for Heart Failure–Related Pulmonary Hypertension.”
