30 Participants Needed

Denervation System for Heart Failure and Pulmonary Hypertension

(PreVail-PH2 Trial)

Recruiting at 5 trial locations
JM
AV
JM
Overseen ByJason McCarthy
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Gradient Denervation Technologies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you have been on stable, guideline-directed medical treatment for at least 3 months before participating, so you should not stop your current medications.

What data supports the effectiveness of the treatment Gradient Denervation System for heart failure and pulmonary hypertension?

Research shows that pulmonary artery denervation, a technique similar to the Gradient Denervation System, can safely reduce pulmonary artery pressure and improve quality of life in patients with pulmonary hypertension. Initial studies have shown positive effects on heart function and symptoms, although more large-scale trials are needed to confirm these findings.12345

Is the denervation system for heart failure and pulmonary hypertension safe for humans?

Initial studies and trials suggest that pulmonary artery denervation, a similar technique, can be performed safely in humans, showing some positive effects on heart and lung function. However, more large-scale studies are needed to confirm its safety and effectiveness.13678

How is the Gradient Denervation System treatment different from other treatments for heart failure and pulmonary hypertension?

The Gradient Denervation System is unique because it involves pulmonary artery denervation, a novel approach that aims to reduce the sympathetic nerve activity in the pulmonary arteries, potentially lowering blood pressure in the lungs and improving heart function. This method is different from traditional drug therapies and is still being studied for its long-term effectiveness and safety.12359

What is the purpose of this trial?

This trial tests a new procedure called PADN that reduces nerve activity in lung arteries. It aims to help heart failure patients with pulmonary hypertension, who currently have no other treatments. By calming these nerves, it may lower lung blood pressure and improve heart function. Pulmonary artery denervation (PADN) has been clinically shown to be effective in controlling pulmonary hypertension.

Eligibility Criteria

This trial is for heart failure patients with a specific type of high blood pressure in the lungs (Group 2 Pulmonary Hypertension). Participants must have a certain level of heart function, kidney function, and meet other specific health measures. They should be experiencing moderate symptoms but on stable treatment.

Inclusion Criteria

Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise
Glomerular Filtration Rate (GFR) ≥ 25 ml/min
N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
See 6 more

Exclusion Criteria

Unable to tolerate right heart catheterization
I have severe leakage in my heart valves.
I don't have major issues with my pulmonary artery that would prevent safe treatment.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulmonary artery denervation using the Gradient Denervation System

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Multiple visits (in-person)

Treatment Details

Interventions

  • Gradient Denervation System
Trial Overview The study is testing the Gradient Denervation System to see if it improves quality of life for these patients. It's an early-stage study focusing on how this procedure affects people with both heart failure and pulmonary hypertension.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PADN with Gradient Denervation SystemExperimental Treatment1 Intervention
Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Gradient Denervation System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Gradient Denervation System for:
  • Investigational use only for Pulmonary Hypertension Group 2 in heart failure patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gradient Denervation Technologies

Lead Sponsor

Trials
3
Recruited
60+

Findings from Research

Pulmonary artery denervation is a promising new treatment for pulmonary arterial hypertension that aims to reduce sympathetic activity in the pulmonary circulation, showing safety and some positive effects in initial studies.
Despite its potential, the use of pulmonary artery denervation is currently limited due to the lack of large-scale, well-designed randomized controlled trials to fully establish its efficacy and scope in clinical practice.
Pulmonary artery denervation for pulmonary arterial hypertension.Constantine, A., Dimopoulos, K.[2021]
In patients with advanced heart failure, those with a diastolic pressure gradient (DPG) of ≥7 mmHg showed persistently lower pulmonary capacitance and higher pulmonary vascular resistance after receiving a left ventricular assist device (LVAD), indicating ongoing pulmonary vascular issues.
Despite these residual abnormalities, the increase in peak oxygen uptake (VO2) post-LVAD was similar between patients with DPG ≥7 mmHg and those with DPG <7 mmHg, suggesting that LVADs can improve exercise capacity regardless of initial DPG levels, with improvements linked to reductions in right atrial pressure and increased heart rate during exercise.
The effect of left ventricular assist device therapy in patients with heart failure and mixed pulmonary hypertension.Lim, HS., Howell, N., Ranasinghe, A.[2018]
In a study of 140 patients with mitral valve defects and high pulmonary hypertension, the addition of circular radiofrequency denervation of the pulmonary trunk and pulmonary artery orifices significantly reduced secondary pulmonary hypertension and improved heart chamber remodeling.
This denervation technique also enhanced the outcomes of the Maze IV procedure, leading to better restoration of sinus rhythm in patients, indicating its potential as a safe and effective surgical intervention for those with complicated atrial fibrillation and high pulmonary hypertension.
[Circular Sympathetic Pulmonary Artery Denervation in Cardiac Surgery Patients With Mitral Valve Defect, Atrial Fibrillation and High Pulmonary Hypertension].Trofimov, NA., Medvedev, AP., Babokin, VY., et al.[2020]

References

Pulmonary artery denervation for pulmonary arterial hypertension. [2021]
The effect of left ventricular assist device therapy in patients with heart failure and mixed pulmonary hypertension. [2018]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Circular Sympathetic Pulmonary Artery Denervation in Cardiac Surgery Patients With Mitral Valve Defect, Atrial Fibrillation and High Pulmonary Hypertension]. [2020]
Meta-Analysis of Pulmonary Artery Denervation for Treatment of Pulmonary Hypertension. [2022]
3-Year Outcome in Patients With Combined Precapillary and Postcapillary Pulmonary Hypertension: Results From PADN-5 Trial. [2023]
Blood pressure and adverse events during continuous flow left ventricular assist device support. [2015]
Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. [2015]
Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™. [2022]
Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial. [2023]
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