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Procedure
Pulmonary Artery Denervation for Pulmonary Hypertension (TROPHY-II 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
Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
Patient with a current diagnosis of NYHA functional class II/III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
TROPHY-II Trial Summary
This trial is testing a new system to treat PH by denerving, or cutting, the pulmonary arteries. The study will follow patients to see if this improves their symptoms, including how far they can walk, their quality of life, and how their heart is functioning.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since the trial involves a procedure rather than a drug intervention, side effects may include typical risks associated with invasive procedures such as bleeding, infection at the catheter site, or potential damage to blood vessels or the heart.
TROPHY-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pulmonary hypertension was confirmed by a special heart and lung test.
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I have moderate heart condition symptoms.
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I have pulmonary hypertension from heart disease and am on stable heart medication.
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My kidney function is within the required range.
TROPHY-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Procedural related Adverse Events (complications) at up to 30 days post procedure
Secondary outcome measures
Change in NT-BNP levels
Change in exercise cardiac index
Change in exercise mean pulmonary artery pressure
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Who is running the clinical trial?
SoniVie Inc.Lead Sponsor
4 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant narrowing in my lung arteries.You are expected to live for less than a year.My pulmonary hypertension was confirmed by a special heart and lung test.I have moderate heart condition symptoms.I am not currently participating in another clinical trial for a drug or device, except for observational studies.I have pulmonary hypertension from heart disease and am on stable heart medication.I have an aneurysm in my lung's artery.I have had a heart attack, unstable chest pain, or stroke in the last 6 months.I am currently having a severe episode of heart failure.I am 18 years old or older.You have certain heart devices implanted less than three months ago, or other implanted medical devices like Cardiomems or neurostimulators.My lung artery shape prevents certain treatments.My kidney function is within the required range.
Research Study Groups:
This trial has the following groups: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to participate in this experiment?
"The information found on clinicaltrials.gov specifies that, as of now, this medical study is not recruiting new participants. The project was first posted on November 30th 2018 and last updated on September 28th 2022; however, there are 1067 other trials actively seeking patients at the present time."
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