First U.S. Patients Enrolled in Clinical Study of a New Therapy to Address a Serious Complication of Heart Disease

DETROIT – Henry Ford Health has performed the first procedures globally in a clinical trial evaluating pulmonary artery denervation, an investigational treatment for people with pulmonary hypertension related to heart disease, a serious condition that can affect breathing, exercise capacity and quality of life.

The minimally invasive procedures were performed Aug. 21 at Henry Ford Hospital in Detroit on the first two patients enrolled globally in the PULSE-LHD study.

Researchers hope the study will help determine whether the investigational approach could eventually expand options for patients living with this condition, which can cause shortness of breath, fatigue, and reduced ability to perform everyday activities.

"This milestone reflects Henry Ford Health's commitment to bringing innovative research opportunities to patients with complex cardiovascular disease," said Dr. Waleed Al-Darzi, advanced heart failure and transplant cardiologist and site principal investigator for the study at Henry Ford Health. "We are proud to help advance research that could lead to future treatment options for patients who currently have limited alternatives."

Pulmonary hypertension occurs when blood pressure in the vessels that carry blood from the heart to the lungs becomes elevated. In some patients, the condition develops as a consequence of left heart disease and can significantly affect quality of life while increasing the risk of hospitalization and other serious health complications.

The procedures were performed as part of the PULSE-LHD clinical trial, a multicenter study evaluating the investigational treatment. The catheter-based procedure is designed to target nerves surrounding the pulmonary artery that may contribute to elevated pressures in the lungs.

The procedure is performed through a small catheter inserted into a blood vessel and advanced to the pulmonary artery, where treatment is delivered. The study treatment uses an investigational medical device that has not been approved by the U.S. Food and Drug Administration for commercial use in the United States.

The milestone comes as results from a separate study evaluating pulmonary artery denervation were recently published in the New England Journal of Medicine. Investigators reported preliminary findings in patients treated in China while noting the importance of continued evaluation through additional studies using rigorous research methods.

The PULSE-LHD trial is designed to further evaluate the safety and effectiveness of the investigational treatment using a randomized, sham-controlled study design. Participants are assigned to either receive pulmonary artery denervation or undergo a comparable procedure without treatment delivery, allowing researchers to more accurately assess outcomes while reducing the potential influence of patient or physician expectations.

Interventional cardiologists Dr. Vikas Aggarwal and Dr. Brian O’Neill performed the procedures on the first U.S. patients, and Dr. Sharon Raymond-Forde, a pulmonary hypertension specialist, is also a co- investigator in the trial.

"Clinical trials play a critical role in helping us improve care for future patients," said Dr. Aggarwal, who is the director of pulmonary vascular interventions at Henry Ford Health. "Studies such as PULSE-LHD help us evaluate investigational therapies using the highest standards of scientific research while offering eligible patients an opportunity to participate in advancing cardiovascular medicine."

The PULSE-LHD study is sponsored by Pulnovo Medical and is being conducted at select sites in the United States and internationally. Henry Ford Health is the only site in Michigan conducting the study.

Henry Ford Health has a long history of participation in leading cardiovascular research studies and offers patients access to clinical trials across a wide range of heart and vascular conditions.

###

MEDIA INQUIRIES: mediarelations@hfhs.org

Interested in learning whether you may qualify for the PULSE-LHD clinical trial? Patients and physicians can call 877-434-7470 for more information. Additional study information is available at ClinicalTrials.gov.