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

Study acronym: The PULSE-LHD
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Trial sites expanded: 13 → 16 locations
    • Trial sites expanded: 6 → 13 locations
  2. Study sites: 6 to 13 Show 4 more changesShow less
    • Start date changed from estimate of Jul 30, 2026 to Aug 21, 2026
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 1 of 13 entries
    • Study description expanded, about 2 words
  3. Trial sites expanded: 3 → 6 locationsv4
  4. Recruitment opened
    • Start date: Apr 1, 2026 to Jul 30, 2026
    • Trial sites expanded: 0 → 3 locations
    v3
  5. Start date: Dec 1, 2025 to Apr 1, 2026v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07214376
Lead Sponsor Pulnovo Medical, Inc.
Conditions
(from sponsor)		 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
Related terms Cardiovascular Diseases, Heart Failure, Hypertension, Hypertension, Pulmonary, Vascular Diseases
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov