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

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

NCT05951166•Gradient Denervation Technologies

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

22 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Tbilisi Heart Clinic

Tbilisi, Georgia

Key Dates

Start Date

May 5, 2023

Primary Completion Date

July 31, 2024

Completion Date

July 1, 2025

Last Updated

March 5, 2025

Enrollment

ACTUAL participants

Conditions

Heart Failure Patients With Pulmonary Hypertension

Interventions

Gradient Denervation System

DEVICE