NCT06052072

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Feb 2024Jul 2028

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

September 18, 2023

Last Update Submit

May 18, 2026

Conditions

Group 2 Pulmonary HypertensionHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Device related serious adverse events

    Frequency of SAEs deemed to be related to the investigational device and/or procedure.

    Through 30 days post-treatment

Secondary Outcomes (1)

  • Mean change from baseline in Pulmonary Vascular Resistance (woods units)

    Measured at 6 months post-treatment

Study Arms (1)

PADN with Gradient Denervation System

EXPERIMENTAL

Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Device: Gradient Denervation System

Interventions

Gradient Denervation SystemDEVICE

Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

PADN with Gradient Denervation System

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 1 months prior treatment

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Aurora Health

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single arm, multi-center, early feasibility study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

February 20, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(8)