Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Description

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

Conditions

Group 2 Pulmonary Hypertension, Heart Failure

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Study Overview

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Study Details

Study overview

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

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Condition
Group 2 Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27708

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Madison

University of Wisconsin, Madison, Wisconsin, United States, 53705

Milwaukee

Aurora Health, Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
  • * 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)

Ages Eligible for Study

22 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gradient Denervation Technologies,

Study Record Dates

2028-07-01