Denervation System for Heart Failure and Pulmonary Hypertension
(PreVail-PH2 Trial)
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pulmonary artery denervation using the Gradient Denervation System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gradient Denervation System
Gradient Denervation System is already approved in United States for the following indications:
- 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