Enhancor System for Combined Pulmonary Hypertension

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 N/A Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
750 (estimated)
Sponsor
Pulnovo Medical, Inc. · Industry
Who this trial is looking for

This trial is looking for patients with heart failure and pulmonary hypertension. Participants will receive a specific treatment and be monitored for three years to evaluate safety and effectiveness.

Are You a Good Fit for This Trial?
Must be taking Guideline-directed medical therapy for heart failure
Rules you out Severe respiratory diseaseSevere liver insufficiencySevere renal insufficiency

You may be able to join if

  • I am between 18 and 85 years old
  • I have chronic heart failure due to left-sided heart disease
  • I am stable and have not been hospitalized for heart failure in the last month
  • I have a specific level of pulmonary artery pressure
  • I have heart failure symptoms that limit my activities
  • I have a walking distance limited by shortness of breath or fatigue
  • I am willing to follow the study requirements and attend visits
  • I can give consent to participate in the study

You may not be able to join if

  • I have a life expectancy of less than 1 year due to other health issues
  • I have severe heart valve issues
  • I have had a stroke or transient ischemic attack in the last 30 days
  • I have severe kidney or liver problems
  • I have an active infection or require long-term immunosuppressants
  • I have severe respiratory disease
  • I am allergic to certain medications related to the procedure
  • I have had major heart surgery in the last 6 months

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject is ≥18 and ≤85 years of age 2. Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as approp…
Contacts

MOFFETT LAURA MARY GINTANT

+1 952 303 2821

laura.moffett@pulnovomed.com

CONTACT

Mark Gu

+08 13774217349

mark.g@pulnovomed.com

CONTACT