Pulmonary Artery Denervation Trial Targets Heart Failure and Pulmonary Hypertension

Pulnovo Medical enrolled the first United States patients in its PULSE-LHD IDE trial, evaluating pulmonary artery denervation for pulmonary hypertension associated with left heart disease, according to company announcements and reporting by Medical Daily.

Detroit doctors treated the first two U.S. patients in the clinical trial targeting nerves around the lung artery, as reported by Medical Daily. The procedure aims to address sympathetic overactivity, which aggravates pulmonary hypertension secondary to left-sided heart failure. According to documentation from Ovid.com, heart failure affects over 37.7 million individuals globally.

Management of heart failure typically involves long-term medication use, but evidence-based therapies vary by left ventricular ejection fraction grouping, according to Ovid.com. Furthermore, drugs approved for pulmonary arterial hypertension are not recommended for treating pulmonary hypertension associated with left heart disease, making the condition a significant clinical challenge due to elevated pulmonary vascular resistance and increased pulmonary arterial pressure.

Clinical Trial Design and Protocol Organization

The PULSE-LHD IDE trial operates as a multicenter study assessing the superiority of adding pulmonary artery denervation to guideline-directed medical therapy. According to Ovid.com, the parallel PADN-HF-PH trial (NCT05824923) is designed to evaluate clinical worsening events based on the 2023 European Society of Cardiology Guidelines for heart failure.

Study organization involves principal investigators overseeing protocol design, alongside dedicated steering committees that monitor procedural processes, scientific integrity, and data analysis accuracy. Participating centers received ethical approval from institutional review boards, including the General Hospital of Northern Theater Command and Nanjing First Hospital, with protocol number KY20220701-07 and ethical approval number (2023) 27, according to Ovid.com records.

Upcoming Data Presentations and ESC Congress 2026

Ahead of key trial data releases, Pulnovo Medical showcased its pulmonary artery denervation technology at the ESC Congress 2026, according to TipRanks. The presentation highlights ongoing developments in device-based interventions for cardiopulmonary disorders.

Preclinical data previously indicated that sympathetic nerves primarily cluster in the posterior region of the bifurcation and the left lateral wall of the pulmonary artery trunk, as detailed by Ovid.com. Prior applications of pulmonary artery denervation in pulmonary arterial hypertension patients improved hemodynamic parameters and increased the 6-minute walk distance. The current U.S. trial enrollment marks an expansion of this evaluation into left heart disease populations.