Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension

Study Purpose

Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with 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) ≥ 1.7 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:

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

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

- Systemic infection or localized infection/rash at planned access site at time of procedure.

- Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months.

- CRT or other Interventional cardiac procedure (except RHC) within last 3 months.

- Any planned cardiac procedure or inpatient procedure within the next 30 days

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.	NCT05951166
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	Georgia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Heart Failure Patients With Pulmonary Hypertension

Arms & Interventions

Arms

Experimental: PADN with Gradient Denervation System

Interventions

Device: - Gradient Denervation System

Pulmonary artery denervation (PADN) procedure

Contact a Trial Team

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