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

Gradient Denervation Technologies2 sites in 1 country5 target enrollmentMay 5, 2023

ConditionsHeart Failure Patients With Pulmonary Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure Patients With Pulmonary Hypertension
Sponsor: Gradient Denervation Technologies
Enrollment: 5
Locations: 2
Primary Endpoint: Device related serious adverse events
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

May 5, 2023

End Date

July 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gradient Denervation Technologies

Responsible Party

Sponsor

Eligibility 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