Denervation System for Heart Failure and Pulmonary Hypertension
(PreVail-PH2 Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Gradient Denervation Technologies
Disqualifiers: Life expectancy < 1 year, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
13678How 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.
12359Eligibility 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
+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.
+4 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of WisconsinMadison, WI
Baylor College of MedicineHouston, TX
Northwestern UniversityChicago, IL
Aurora HealthMilwaukee, WI
More Trial Locations
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Who Is Running the Clinical Trial?
Gradient Denervation TechnologiesLead Sponsor
References
Pulmonary artery denervation for pulmonary arterial hypertension. [2021]Pulmonary arterial hypertension remains a progressive, life-limiting disease despite optimal medical therapy. Pulmonary artery denervation has arisen as a novel intervention in the treatment of pulmonary arterial hypertension, and other forms of pulmonary hypertension, with the aim of reducing the sympathetic activity of the pulmonary circulation. Pre-clinical studies and initial clinical trials have demonstrated that the technique can be performed safely with some positive effects on clinical, haemodynamic and echocardiographic markers of disease. The scope of the technique in current practice remains limited given the absence of well-designed, large-scale, international randomised controlled clinical trials. This review provides an overview of this exciting new treatment modality, including pathophysiology, technical innovations and recent trial results.
The effect of left ventricular assist device therapy in patients with heart failure and mixed pulmonary hypertension. [2018]Diastolic pressure gradient (DPG) of ≥7 mmHg has been proposed to distinguish mixed pulmonary hypertension from isolated post-capillary pulmonary hypertension in heart failure (HF). We evaluated the changes in pulmonary hemodynamics with left ventricular assist devices (LVADs) in patients with DPG of ≥7 or
[Circular Sympathetic Pulmonary Artery Denervation in Cardiac Surgery Patients With Mitral Valve Defect, Atrial Fibrillation and High Pulmonary Hypertension]. [2020]Objective Investigate the influence of the sympathetic denervation of the pulmonary trunk and the orifices of the pulmonary arteries on the degree of pulmonary hypertension (PH) and outcomes of the surgical treatment of atrial fibrillation (AF) in patients with mitral valve defects, complicated AF, and high PH.Material and methods We analyzed the surgical treatment of 140 patients with mitral valve defect, concomitant AF, and high PH - pulmonary artery systolic pressure (PASP) gradient more than 40 mm Hg. The group of interest included 51 patients (46 patients with severe mitral stenosis and five patients with grade 4 mitral valve regurgitation). All patients underwent mitral valve correction (47 valve replacement surgeries and 4 valve-sparing interventions), biatrial Maze IV procedure, and additionally, denervation of the pulmonary trunk and the orifices of the pulmonary arteries. The control group included 89 patients diagnosed with mitral valve defect, AF, and PH with PASP > 40 mm Hg. However, unlike in patients of interest, denervation of the pulmonary arteries was not performed.Results Circular radiofrequency denervation of the pulmonary trunk and the orifices of the pulmonary arteries using a clamp-destructor is an effective and safe method, significantly reduces secondary PH (p=0.018), promotes reverse remodeling of the heart chambers, left atrium in particular (p=0.01), and improves outcomes of the Maze IV procedure (p=0.022) by restoring sinus rhythm in patients with mitral valve defects, complicated AF, and high PH.Conclusion This technique must be studied further involving a more significant number of patients, analyzing long-term results, and using this technique in patients with non-valvular causes of secondary PH.
Meta-Analysis of Pulmonary Artery Denervation for Treatment of Pulmonary Hypertension. [2022]Pulmonary artery denervation (PADN) can reduce the sympathetic nervous system (SNS) activity, reduce pulmonary artery pressure (PAP), and improve the quality of life in patients with pulmonary hypertension (PH). We conducted a systematic meta-analysis of the effectiveness of PADN in the treatment of PH patients.
3-Year Outcome in Patients With Combined Precapillary and Postcapillary Pulmonary Hypertension: Results From PADN-5 Trial. [2023]Long-term benefits of pulmonary artery denervation (PADN) for patients with combined precapillary and postcapillary pulmonary hypertension (CpcPH) secondary to left heart failure are unknown.
Blood pressure and adverse events during continuous flow left ventricular assist device support. [2015]Adverse events (AEs), such as intracranial hemorrhage, thromboembolic event, and progressive aortic insufficiency, create substantial morbidity and mortality during continuous flow left ventricular assist device support yet their relation to blood pressure control is underexplored.
Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. [2015]We review differences in the incidence and timing of adverse events in patients implanted with continuous-flow left ventricular assist devices (LVADs), using the Mechanical Circulatory Support Research Network registry.
Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™. [2022]Device exchange to a newer generation left ventricular assist device (LVAD) offers the opportunity to benefit from improved adverse events profiles. We present the three-year results of a patient cohort undergoing VAD upgrades to a new generation device focusing on outcomes and adverse events.
Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial. [2023]World Health Organization (WHO) group 1 pulmonary arterial hypertension (PAH) is a progressive, debilitating disease. Previous observational studies have demonstrated that pulmonary artery denervation (PADN) reduces pulmonary artery pressures in PAH. However, the safety and effectiveness of PADN have not been established in a randomized trial.