RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Pulmonary Artery Denervation (PADN) for Pulmonary Hypertension

The goal of this clinical study is to measure the safety and how well it works 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 randomly assigned 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.

Official registry: https://clinicaltrials.gov/study/NCT07214376 · Pulnovo Medical, Inc. · enrollment listed as 750

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pulmonary Artery Denervation (PADN), or Sham procedure control. The registry lists allocation as randomized. The goal of this clinical study is to measure the safety and how well it works 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).

They plan to enroll about 750 people at 19 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: Pulmonary Artery Denervation (PADN), Sham procedure control

Primary outcome (registry wording): Primary Efficacy Endpoint

Who it is for (from inclusion criteria)

Ages 18 Years to 85 Years
Subject is ≥18 and ≤85 years of age
Subject is clinically stable, defined as:
SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)
PASP (RVSP) is ≥30 mmHg on the baseline TTE
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)
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
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)

Who the registry excludes

Subject has a life expectancy of less than 1 year due to non-cardiovascular causes
Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve
Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4
Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)
Subjects with a known bleeding diathesis or who will refuse blood transfusions
Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation
Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis

Public study contact (from the registry)

MOFFETT LAURA MARY GINTANT

+1 952 303 2821

laura.moffett@pulnovomed.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

19 listed

Banner - University Medical Center Tucson — Tucson, Arizona (recruiting)
Yale University — New Haven, Connecticut (recruiting)
Washington Hospital Center — Washington D.C., District of Columbia (recruiting)
Cleveland Clinic Florida - Weston — Weston, Florida (recruiting)
Cardiovascular Institute of the South — Houma, Louisiana (recruiting)
Boston Medical Center — Boston, Massachusetts (recruiting)
Henry Ford Hospital — Detroit, Michigan (recruiting)
North Shore University Hospital — Manhasset, New York (recruiting)
Mount Sinai Morningside — New York, New York (recruiting)
NewYork-Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York (not_yet_recruiting)
Weill Cornell Medical Center — New York, New York (recruiting)
Cleveland Clinic — Cleveland, Ohio (recruiting)

+ 4 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07214376 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07214376?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07214376?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary