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Enhancor System for Pulmonary Hypertension with Left Heart Disease

This study is testing a new procedure called Pulmonary Artery Denervation (PADN) using the Enhancor System. PADN involves using a special catheter to apply radiofrequency energy to the pulmonary artery. The goal is to see if this procedure is safe and effective for people with combined pre- and post-capillary pulmonary hypertension (high blood pressure in the lungs) that is linked to left heart disease (heart problems affecting the left side of your heart). You might be able to join if you are 18 to 85 years old, have chronic heart failure, and are already receiving standard medical care for your heart condition. The study will compare the Enhancor System to a sham procedure (a fake procedure) to see if it improves your condition. The main things being measured are how well the treatment works and its safety within 30 days.

Study design
This is a randomized study with 750 participants. You would be randomly assigned to either receive the PADN procedure or a sham procedure, in addition to your usual medical therapy.
What's involved
Participants will have follow-up visits at 1, 6, 12, 24, and 36 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 years after the procedure.

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NCT07214376

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

Recruiting
NAAges 18–85InterventionalTreatment
Pulnovo Medical, Inc.
~750 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Pulmonary Artery Denervation (PADN)Sham procedure control

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Efficacy Endpoint
Measured over Immediately after the randomization to last enrolled patient reaches 12-month follow-up
+1 more outcome measured

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

Explore related trials

Heart FailurePulmonary Hypertension due to Left Heart Disease

NCT07214376

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner - University Medical Center Tucson

    Tucson, Arizonastudy coordinator listed

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisianastudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Henry Ford Hospital

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Oklahoma Heart Institute

    Tulsa, Oklahomastudy coordinator listed

    Recruiting

  • University of Pittsburgh Medical Center

    Mechanicsburg, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gregg W. Stone · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

MOFFETT LAURA MARY GINTANT
[email protected]
+1 952 303 2821
Email the study team

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Eligibility criteria

Inclusion

No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure
SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation) 4. PASP (RVSP) is ≥30 mmHg on the baseline TTE. 5. Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications). 6. Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues 7. Subject has NT-proBNP ≥600 pg/mL for patients with LVEF ≤40% or ≥200 pg/mL for patients with LVEF \>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP) 8. Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing. 9. Subject or the subject's legally designated representative signs an IRB/EC approved informed consent form prior to study participation.

What this trial measures

  • Primary Efficacy EndpointImmediately after the randomization to last enrolled patient reaches 12-month follow-up

    Composite of Major Heart Failure Events (MHFE). Based on a time-to-first event analysis at 24-month follow-up evaluated when the last enrolled patient reaches 12-month follow-up: 1. Cardiovascular death; 2. Heart transplantation or durable left ventricular assist device (LVAD) implantation; 3.HF hospitalizations; 4. Outpatient worsening HF events

  • Primary Safety Endpoint30-days

    Composite of Device-related or Procedre-related Major Adverse Events (MAEs) in the treatment group compared with a performance goal