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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Gradient Denervation Technologies
Study ID
NCT06052072
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 20, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jul 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PADN with Gradient Denervation System
    Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Primary Outcome Measure

Device related serious adverse events [ Time Frame: Through 30 days post-treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Massachusetts General HospitalBostonMassachusetts02114-
Duke UniversityDurhamNorth Carolina27708-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Baylor College of MedicineHoustonTexas77030-
Houston MethodistHoustonTexas77030-
University of WisconsinMadisonWisconsin53705-
Aurora HealthMilwaukeeWisconsin53215-

Find similar trials in Chicago, IL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Northwestern University· Chicago, ILMassachusetts General Hospital· Boston, MADuke University· Durham, NCMedical University of South Carolina· Charleston, SCBaylor College of Medicine· Houston, TXHouston Methodist· Houston, TX

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