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Procedure

Denervation System for Heart Failure and Pulmonary Hypertension (PreVail-PH2 Trial)

N/A
Recruiting
Research Sponsored by Gradient Denervation Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA Class II or III
Be older than 18 years old
Must not have
Severe aortic, mitral or pulmonary valve regurgitation
Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 1- and 6- months post-procedure
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this is an early feasibility study, detailed side effects are not provided. However, procedures like denervation could potentially cause complications such as bleeding, infection or damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate heart condition symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe leakage in my heart valves.
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I cannot take certain blood thinners due to allergies or other reasons.
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I don't have major issues with my pulmonary artery that would prevent safe treatment.
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I have a leaky heart valve and liver issues due to cirrhosis or heart-related liver problems.
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I do not have blood clots in the areas to be treated in my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 1- and 6- months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 1- and 6- months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device and procedure related serious adverse events
Secondary study objectives
Change in PVR

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and cardiac resynchronization therapy (CRT). ACE inhibitors reduce blood pressure and decrease the workload on the heart by inhibiting the conversion of angiotensin I to angiotensin II. Beta-blockers slow the heart rate and reduce blood pressure by blocking the effects of adrenaline. Diuretics help remove excess fluid from the body, reducing the strain on the heart. CRT improves the timing of the heart's contractions by coordinating the action of the left and right ventricles. Pulmonary artery denervation, similar to these treatments, aims to reduce pulmonary artery pressure by disrupting sympathetic nerve activity. This is crucial for heart failure patients as it can alleviate symptoms, improve quality of life, and potentially reduce hospitalizations by addressing the underlying hemodynamic abnormalities.
Cardiac and pulmonary arterial remodeling after sinoaortic denervation in normotensive rats.

Find a Location

Who is running the clinical trial?

Gradient Denervation TechnologiesLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
2 Trials studying Heart Failure
35 Patients Enrolled for Heart Failure
~8 spots leftby Feb 2025
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