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ACTIVE NOT RECRUITING
NCT03611270
NA

TReatment of Pulmonary Hypertension Group II Study

Sponsor: SoniVie Inc.

View on ClinicalTrials.gov

Summary

The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR\>3 wood units.

Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2018-11-30

Completion Date

2027-07

Last Updated

2023-08-21

Healthy Volunteers

No

Interventions

DEVICE

Pulmonary Denervation

Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.

Locations (3)

UC San Diego Medical Center

San Diego, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States