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

Part of paid clinical trials in Houma, Louisiana.

Sponsor
Pulnovo Medical, Inc.
Study ID
NCT07214376
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Pulmonary Artery Denervation (PADN) — DEVICE
    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)
  • Sham procedure control — DEVICE
    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)

Study Details

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.

Key Dates

Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pulmonary Artery Denervation (PADN)
    PADN plus GDMT
  • Active Comparator: Control
    Placebo-procedure plus GDMT

Primary Outcome Measure

Primary Efficacy Endpoint [ Time Frame: Immediately after the randomization to last enrolled patient reaches 12-month follow-up ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cardiovascular Institute of the SouthHoumaLouisiana70360
Peter Fail
[email protected]
985-876-0300
Oklahoma Heart InstituteTulsaOklahoma74104
Steven Chase Stroud
[email protected]
574-937-5263
University of Pittsburgh Medical CenterMechanicsburgPennsylvania17050
Amy Goodrich-Harris
[email protected]
717-731-0101

Find similar trials in Houma, LA

By condition
Heart failureHypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Cardiovascular Institute of the South· Houma, LAOklahoma Heart Institute· Tulsa, OKUniversity of Pittsburgh Medical Center· Mechanicsburg, PA

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