Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
NCT ID: NCT05951166
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
5 participants
INTERVENTIONAL
2023-05-05
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PADN with Gradient Denervation System
Gradient Denervation System
Pulmonary artery denervation (PADN) procedure
Interventions
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Gradient Denervation System
Pulmonary artery denervation (PADN) procedure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
85 Years
ALL
No
Sponsors
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Gradient Denervation Technologies
INDUSTRY
Responsible Party
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Locations
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Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Tbilisi Heart Clinic
Tbilisi, , Georgia
Countries
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Other Identifiers
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CIP-001
Identifier Type: -
Identifier Source: org_study_id
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