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Procedure
TIVUS™ System for Pulmonary Hypertension (TROPHY 1-US Trial)
N/A
Waitlist Available
Research Sponsored by SoniVie Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 3, 4 and 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the safety and effectiveness of the TIVUS™ System for treating pulmonary artery hypertension. Up to 15 patients will be enrolled in this prospective, open-label study at 4 centers.
Eligible Conditions
- Pulmonary Arterial Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2, 3, 4 and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 3, 4 and 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amount of all procedural related adverse event as assessed by the CEC
Amount of treatment related adverse event as assessed by the CEC
Number of patient with PAH worsening and all cause death events
Secondary study objectives
Clinical effectiveness
Clinical efffectivness
Other study objectives
Observational Variables
Observational Variables - Long term surveillance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
SoniVie Inc.Lead Sponsor
5 Previous Clinical Trials
521 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
220 Patients Enrolled for Pulmonary Arterial Hypertension
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving treatment with injectable prostanoids.You are not expected to live for more than a year.Your kidney function, measured by eGFR or serum creatinine levels, is within a certain range.You have a moderate to severe narrowing in your lung's main artery.You have a bulging blood vessel in your lungs.You have had a heart attack, unstable chest pain, or a stroke in the past 6 months.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.You cannot have an MRI scan.You have a specific type of pulmonary artery anatomy that makes treatment not possible.You are taking more than two specific medications for pulmonary arterial hypertension, not including parenteral prostanoids.You have been diagnosed with pulmonary arterial hypertension and have specific measurements showing high pressure in the arteries of your lungs, low pressure in the left side of your heart, and high resistance in the blood vessels of your lungs. You did not respond well to a vasodilator test.
Research Study Groups:
This trial has the following groups:- Group 1: Pulmonary Denervation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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