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

March 3, 2025 updated by: Gradient Denervation Technologies
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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 Locations

  • Georgia
      • Tbilisi, Georgia
        • Israeli-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Georgia
        • Tbilisi Heart Clinic

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:

  • 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
  • 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:

  • Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
  • Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
  • Systemic infection or localized infection/rash at planned access site at time of procedure
  • Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
  • CRT or other Interventional cardiac procedure (except RHC) within last 3 months
  • Any planned cardiac procedure or inpatient procedure within the next 30 days

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
Pulmonary artery denervation (PADN) procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device related serious adverse events
Time Frame: 30 days post-treatment
30 days post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Time Frame: 6- months post-treatment
6- months post-treatment

Collaborators and Investigators

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

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 Major Dates

Study Start (Actual)

May 5, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-001

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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