Trials / Not Yet Recruiting

Not Yet RecruitingNCT07214376

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

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 750 (estimated)

Sponsor: Pulnovo Medical, Inc. · Industry
Sex: All
Age: 18 Years – 85 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

Roll-in Subjects: Prior to enrollment of the first randomized subject at each site, up to two roll-in subjects per operator (maximum 2 operators per site) who meet all eligibility criteria for the randomized trial may be enrolled. Roll-in subjects will receive PADN plus GDMT. Roll-in subjects will undergo all protocol-specified assessments. The sponsor will determine when each operator has achieved acceptable experience with the PADN procedure to advance to the randomized trial, after which no further roll-in patients will be enrolled. Operators who have performed ≥3 prior PADN procedures may not need to enroll a roll-in patient prior to beginning randomization. Randomized Subjects: Subjects with CpcPH due to LHD who meet all eligibility criteria will be randomized in a 1:1 ratio (stratified by investigational site and by core laboratory assessed LVEF \[≤40% vs \>40%\]) to one of the two treatment arms: 1. Intervention: PADN plus GDMT 2. Control: Placebo-procedure plus GDMT Subjects will undergo clinical follow-up at 1, 6, 12, 24 and 36 months. At 24 months, control subjects who have experienced a primary efficacy endpoint event and who still meet all eligibility criteria will be offered the opportunity to cross over to the PADN plus GDMT group.

Conditions

Interventions

Type	Name	Description
DEVICE	Pulmonary Artery Denervation (PADN)	In patients randomized to Intervention, a Contrast pulmonary artery (PA) angiography will be performed to identify the pulmonary artery bifurcation and measure the PA diameter. Once the anatomy is deemed suitable, a radiofrequency ablation catheter will be introduced into the ostium of the left PA and the distal bifurcation of the main PA. The catheter will be maneuvered within the PA to deliver energy circumferentially, ensuring tight electrode contact with the endovascular surface. Approximately three ablations will be performed at a target temperature of 50 °C (range 45-55 °C) for 120 seconds each at both the left PA ostium and the distal main PA bifurcation. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)
DEVICE	Sham procedure control	In patients randomized to a placebo-procedure, a script will be followed for approximately 20 minutes to simulate the PADN procedure. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)

Timeline

Start date: 2026-04-01
Primary completion: 2029-12-31
Completion: 2031-12-31
First posted: 2025-10-09
Last updated: 2026-03-12

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07214376. Inclusion in this directory is not an endorsement.