TIVUS™ System for Pulmonary Hypertension
(TROPHY 1-US Trial)

Recruiting in Palo Alto (17 mi)

+3 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, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.

Research Team

Eligibility Criteria

Inclusion Criteria

Your kidney function, measured by eGFR or serum creatinine levels, is within a certain range.

You have been diagnosed with specific types of pulmonary arterial hypertension (PAH) related to certain medical conditions.

You are currently classified as having severe symptoms according to the World Health Organization.

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Exclusion Criteria

You are currently receiving treatment with injectable prostanoids.

Pregnant women or women planning a pregnancy within 12 months of study enrolment

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

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Treatment Details

Interventions

Therapeutic Intra-Vascular UltraSound (TIVUS™) System (Procedure)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Pulmonary DenervationExperimental Treatment1 Intervention

Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary arterial 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.