Pulmonary Artery Denervation for Pulmonary Hypertension
(TROPHY-II Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: SoniVie Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults over 18 with pulmonary hypertension due to left heart disease, who are in a stable condition on standard medical therapy. They must have specific types of pulmonary hypertension confirmed by tests and be able to give informed consent. People with life-threatening conditions, certain heart devices or anatomy issues, pregnant women, or those in other drug/device trials can't join.

Inclusion Criteria

My pulmonary hypertension was confirmed by a special heart and lung test.

I have moderate heart condition symptoms.

Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure

See 3 more

Exclusion Criteria

I have a significant narrowing in my lung arteries.

You are expected to live for less than a year.

Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry

See 7 more

Treatment Details

Interventions

TIVUS™ System (Procedure)

Trial OverviewThe TIVUS™ System's safety and effectiveness for treating group II pulmonary hypertension are being tested. This non-randomized study will enroll up to 15 patients across up to three centers. It aims to improve clinical parameters like hemodynamics, exercise tolerance, and quality of life.