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

Gradient Denervation Technologies

Status

Active, not recruiting

Conditions

Heart Failure Patients With Pulmonary Hypertension

Treatments

Device: Gradient Denervation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05951166

CIP-001

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

All

Ages

22 to 85 years old

Volunteers

No 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