Back to resultsPulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension (PreVail-PH)
Primary Purpose
Heart Failure Patients With Pulmonary Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Gradient Denervation System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure Patients With Pulmonary Hypertension
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
Sites / Locations
- Israeli-Georgian Medical Research Clinic HelsicoreRecruiting
- Tbilisi Heart ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PADN with Gradient Denervation System
Arm Description
Outcomes
Primary Outcome Measures
Device and procedure related serious adverse events
Secondary Outcome Measures
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Mean change from baseline in 6MWT distance (m)
Full Information
NCT ID
NCT05951166
First Posted
June 12, 2023
Last Updated
July 10, 2023
Sponsor
Gradient Denervation Technologies
1. Study Identification
Unique Protocol Identification Number
NCT05951166
Brief Title
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Acronym
PreVail-PH
Official Title
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gradient Denervation Technologies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Patients With Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PADN with Gradient Denervation System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Gradient Denervation System
Intervention Description
Pulmonary artery denervation (PADN) procedure
Primary Outcome Measure Information:
Title
Device and procedure related serious adverse events
Time Frame
30 days post-ablation
Secondary Outcome Measure Information:
Title
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Time Frame
30 and 120 days post-ablation
Title
Mean change from baseline in 6MWT distance (m)
Time Frame
30 and 120 days post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Messer
Phone
763-657-7036
Email
clinical@gradientdenervation.com
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Chumburdize, MD
Email
t.chumburidze@hcore.ge
Facility Name
Tbilisi Heart Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ketevan Gabunia, MD
Email
kgabunia@tbhc.ge
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
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