RECRUITING

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

Talk to us

Conditions

Group 2 Pulmonary HypertensionHeart Failure

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-02-20
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06052072

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.

Ages Eligible for Study:22 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Heart Failure with EF ≥ 40% (by TTE within last 3 months)
  2. * Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
  3. * Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
  4. * Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
  5. * Cardiac index (CI) ≥ 1.2 L/min/m2
  6. * NYHA Class II or III
  7. * Glomerular Filtration Rate (GFR) ≥ 25 ml/min
  8. * Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
  1. * Ambulatory with a Life expectancy of \< 1 years
  2. * Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
  3. * Unable to tolerate right heart catheterization
  4. * Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
  5. * Severe aortic, mitral or pulmonary valve regurgitation
  6. * Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
  7. * Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

Contacts and Locations

Study Contact

Jason McCarthy
CONTACT
763-657-7036
clinical@gradientdenervation.com

Study Locations (Sites)

Duke University
Durham, North Carolina, 27708
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States
Aurora Health
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Gradient Denervation Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2028-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Group 2 Pulmonary Hypertension
  • Heart Failure