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TIVUS™ System for Pulmonary Hypertension (TROPHY 1-US Trial)
TROPHY 1-US Trial 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.
- Pulmonary Arterial Hypertension
TROPHY 1-US Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TROPHY 1-US Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Pulmonary Denervation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any other healthcare facilities in the city that are conducting this experiment?
"At the present moment, 4 different clinical trials sites are actively enrolling patients. These locations include San Diego, Ann Arbor and New york as well as other nearby centres - making it prudent to select a site that is closest to you in order to limit your travelling costs if chosen for this study."
Are there any open slots for enrollment in this medical experiment?
"According to the information available on clinicaltrials.gov, this particular medical study has ceased enrolling new patients since March 30th 2022. However, there are 765 other trials recruiting now for those looking to partake in a trial."
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