First US Patients enrolled in new pulmonary artery denervation trial
Henry Ford Health in Detroit recently performed the first U.S. procedures in a clinical trial evaluating pulmonary artery denervation as a possible new treatment for pulmonary hypertension.
In late August, Henry Ford Hospital cardiologists performed the minimally invasive procedures on the first two patients enrolled globally in the PULSE-LHD study. The procedures were performed under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE). PULSE-LHD is evaluating whether this pulmonary artery denervation could expand treatment options for patients living with pulmonary hypertension, which is known to cause shortness of breath, fatigue and reduced quality of life by limiting a patient's ability to perform everyday activities.
"The enrollment of the first patients in the PULSE-LHD trial is an exciting step toward evaluating a novel treatment strategy for pulmonary hypertension associated with left heart disease," Waleed Al-Darzi, MD, a Henry Ford Health cardiologist and the study site principal investigator, said in a statement. "This condition affects a large number of patients and remains an area of significant unmet clinical need. We are proud to help lead this important research and look forward to generating evidence that may inform future treatment options for patients."
PULSE-LHD 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.
The procedure uses a radiofrequency (RF) ablation catheter to target nerves surrounding the pulmonary artery that may contribute to elevated pressures in the lungs. The premise is the same as renal denervation procedures to destroy the renal artery sympathetic nerves to eliminate vasoconstriction and permanently dilate the arteries to a full open position, increasing blood flow and reducing high blood pressure.
The multicenter, randomized, placebo-procedure controlled trial will evaluate the safety and efficacy of pulmonary artery denervation in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease (CpcPH-LHD). This is the most prevalent subtype of pulmonary hypertension, making up between 65% and 80% of all cases. There is currently no FDA-cleared therapy for the treatment of CpcPH-LHD.
These groundbreaking procedures came after the recent publication in the New England Journal of Medicine of preliminary findings from the parallel PADN-HF-PH registration trial in China.[1] The data were also presented at the 2026 ESC Congress. Additionally, data from the PADN-Columbus pilot study were presented at EuroPCR 2026. Both studies demonstrated the procedure's initial safety and preliminary signals of benefit in pulmonary hemodynamics and functional capacity.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]