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

NCT05951166 | Active Not Recruiting

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

Conditions

Heart Failure Patients With Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Device related serious adverse events

  30 days post-treatment

Secondary Outcomes (1)

• Mean change from baseline in Pulmonary Vascular Resistance (woods units)

  6- months post-treatment

Study Arms (1)

PADN with Gradient Denervation System

EXPERIMENTAL

Device: Gradient Denervation System

Interventions

Gradient Denervation System DEVICE

Pulmonary artery denervation (PADN) procedure

PADN with Gradient Denervation System

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gradient Denervation Technologies: lead

Study Sites (2)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Location

Tbilisi Heart Clinic

Tbilisi, Georgia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 18, 2023
• Study Start: May 5, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2)