Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Study Purpose

This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Heart Failure with EF ≥ 40% (by TTE within last 3 months) - Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest.

- Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest.

- Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise.

- Cardiac index (CI) ≥ 1.2 L/min/m2.

- NYHA Class II or III.

- Glomerular Filtration Rate (GFR) ≥ 25 ml/min.

- N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL.

- Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment.

Exclusion Criteria:

- Life expectancy of < 2 years.

- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel.

- Unable to tolerate right heart catheterization.

- Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device.

- Severe aortic, mitral or pulmonary valve regurgitation.

- Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy.

- Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06052072
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Gradient Denervation Technologies
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Group 2 Pulmonary Hypertension, Heart Failure

Additional Details

Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.

Arms & Interventions

Arms

Experimental: PADN with Gradient Denervation System

Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Interventions

Device: - Gradient Denervation System

Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 27708

Site Contact

Rose Burns

rose.burns@duke.edu

763-657-7036