Back to resultsPulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study) (PreVail-PH2)
Primary Purpose
Group 2 Pulmonary Hypertension, Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gradient Denervation System
Sponsored by
About this trial
This is an interventional treatment trial for Group 2 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) ≥ 1.2 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: Life expectancy of < 2 years Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel Unable to tolerate right heart catheterization Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device Severe aortic, mitral or pulmonary valve regurgitation Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PADN with Gradient Denervation System
Arm Description
Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Outcomes
Primary Outcome Measures
Device and procedure related serious adverse events
Number and frequency of serious adverse events deemed to be related to the investigational device and/or procedure.
Secondary Outcome Measures
Technical success of the device
The ability to complete the denervation procedure with no device related adverse events
Change in PVR
Mean change from baseline in PVR
Change in 6MWT
Mean change from baseline in 6MWT
Full Information
NCT ID
NCT06052072
First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
Gradient Denervation Technologies
1. Study Identification
Unique Protocol Identification Number
NCT06052072
Brief Title
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Acronym
PreVail-PH2
Official Title
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2027 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Detailed Description
Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Group 2 Pulmonary Hypertension, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single arm, multi-center, early feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PADN with Gradient Denervation System
Arm Type
Experimental
Arm Description
Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Intervention Type
Device
Intervention Name(s)
Gradient Denervation System
Intervention Description
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Primary Outcome Measure Information:
Title
Device and procedure related serious adverse events
Description
Number and frequency of serious adverse events deemed to be related to the investigational device and/or procedure.
Time Frame
Through 30 days post-procedure
Secondary Outcome Measure Information:
Title
Technical success of the device
Description
The ability to complete the denervation procedure with no device related adverse events
Time Frame
Through 1 day post-procedure
Title
Change in PVR
Description
Mean change from baseline in PVR
Time Frame
Measured at 1- and 6- months post-procedure
Title
Change in 6MWT
Description
Mean change from baseline in 6MWT
Time Frame
Measured at 1- and 6- months post-procedure
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) ≥ 1.2 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:
Life expectancy of < 2 years
Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
Unable to tolerate right heart catheterization
Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
Severe aortic, mitral or pulmonary valve regurgitation
Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Messer
Phone
763-657-7036
Email
clinical@gradientdenervation.com
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 Group 2 (PreVail-PH2 Study)
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