No phaseRecruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease (The PULSE-LHD)
A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
- Sponsor
- Pulnovo Medical, Inc. (Industry)
- Enrolment
- 750 planned
- Conditions
- Pulmonary Hypertension; Heart Failure With Reduced Ejection Fraction; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure With Preserved Ejection Fraction; Heart Failure With Mid Range Ejection Fraction
- Interventions
- Pulmonary Artery Denervation (PADN); Sham procedure control
- Ages
- adults, older adults
- Registry
- NCT07214376
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.
Primary outcomes
- Primary Efficacy Endpoint
- Primary Safety Endpoint
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered