Pulmonary Artery Denervation for Heart Failure with Pulmonary Hypertension

A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

Recruiting Phase 3 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. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
264 (estimated)
Sponsor
Pulnovo Medical (Wuxi) Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for adults with chronic heart failure who also have pulmonary hypertension related to left heart disease. Participants will undergo a procedure called pulmonary artery denervation and will be monitored for safety and effectiveness.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been diagnosed with chronic heart failure for at least 3 months.
  • I have been treated with recommended heart failure medication for at least 1 month.
  • I am clinically stable and not taking certain medications for at least 1 month.
  • My systolic blood pressure is between 100 and 160 mmHg.
  • I can walk at least 100 meters.
  • I understand and can sign informed consent.

You may not be able to join if

  • I have certain heart conditions that are not allowed.
  • I have had a stroke or mini-stroke in the past 30 days.
  • I have received any heart surgery in the past 6 months.
  • I plan to undergo any surgery in the next 6 months.
  • I have severe kidney or liver problems.
  • I am pregnant, breastfeeding, or planning to become pregnant in the next year.
  • I have participated in other clinical trials in the past 3 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.

Think this trial could be right for you?

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About This Trial

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥18, ≤75 years old; 2. Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month; 3. Clinically stable defined by 1. No intravenous diuretics…
Contacts

Mark Gu

13774217349

guwen@pulnovomed.com

CONTACT

Yanyan Lu

13914766820

co@pulnovomed.com

CONTACT