Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-06 @ 5:59 PM
Study NCT ID:
NCT05951166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2023-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device related serious adverse events', 'timeFrame': '30 days post-treatment'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in Pulmonary Vascular Resistance (woods units)', 'timeFrame': '6- months post-treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure Patients With Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart Failure with EF ≥ 40% (by TTE within last 3 months)\n* Mean Pulmonary Artery Pressure (mPAP) \\>20 mmHg at rest\n* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest\n* Pulmonary Capillary Wedge Pressure \\> 15 mmHg (at rest) or \\> 18 with passive leg raise\n* Cardiac index (CI) ≥ 1.7 L/min/m2\n* NYHA Class II or III\n* Glomerular Filtration Rate (GFR) ≥ 25 ml/min\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL\n* Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment\n\nExclusion Criteria:\n\n* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel\n* Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device\n* Systemic infection or localized infection/rash at planned access site at time of procedure\n* Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months\n* CRT or other Interventional cardiac procedure (except RHC) within last 3 months\n* Any planned cardiac procedure or inpatient procedure within the next 30 days'}, 'identificationModule': {'nctId': 'NCT05951166', 'acronym': 'PreVail-PH', 'briefTitle': 'Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gradient Denervation Technologies'}, 'officialTitle': 'Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'CIP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PADN with Gradient Denervation System', 'interventionNames': ['Device: Gradient Denervation System']}], 'interventions': [{'name': 'Gradient Denervation System', 'type': 'DEVICE', 'description': 'Pulmonary artery denervation (PADN) procedure', 'armGroupLabels': ['PADN with Gradient Denervation System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Israeli-Georgian Medical Research Clinic Helsicore', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gradient Denervation Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}