Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Group 2 Pulmonary Hypertension
- Sponsor
- Gradient Denervation Technologies
- Enrollment
- 50
- Locations
- 8
- Primary Endpoint
- Device related serious adverse events
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
- •Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
Exclusion Criteria
- •Ambulatory with a Life expectancy of \< 1 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)
Outcomes
Primary Outcomes
Device related serious adverse events
Time Frame: Through 30 days post-treatment
Frequency of SAEs deemed to be related to the investigational device and/or procedure.
Secondary Outcomes
- Mean change from baseline in Pulmonary Vascular Resistance (woods units)(Measured at 6 months post-treatment)