Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study) (PreVailPH2 OUS)

July 30, 2025 updated by: Gradient Denervation Technologies
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • NYHA Class II or III
  • Glomerular Filtration Rate (GFR) ≥ 25 ml/min

Exclusion Criteria:

  • Unwilling to provide informed consent or complete follow-up assessments
  • 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
  • Severe aortic, mitral or pulmonary valve regurgitation
  • Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
  • Systemic infection or localized infection/rash at planned access site at time of procedure
  • CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PADN with Gradient Denervation System
Device: Gradient Denervation System
The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device related serious adverse events
Time Frame: 30-days post-treatment
Frequency of device related SAEs
30-days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Time Frame: 6 month post-treatment
Calculated percent mean change from baseline
6 month post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gradient Denervation Technologies

Investigators

  • Study Director: Julie Etheridge, Gradient

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 Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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