Your session is about to expire
← Back to Search
Rivet Shunt for Pulmonary Hypertension with Heart Failure
Study Summary
This trial is testing a new treatment for pulmonary hypertension, which is high blood pressure in the arteries of the lungs. The treatment is called Rivet PVS, and it is being studied to see if it is safe and effective.
- Heart Failure
- Pulmonary Hypertension
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- Your average RAP (right atrial pressure) is higher than 12 mmHg when measured at rest while breathing room air.You have pulmonary hypertension due to certain causes.You can walk at least 150 meters in six minutes.You have a chronic lung disease and need oxygen at home, have been hospitalized recently, or have a specific breathing test result.You have been diagnosed with certain types of heart problems and have specific test results to confirm it.You have ongoing serious heart problems with specific symptoms, hospitalization for heart failure, or a certain blood test result.You are currently receiving the recommended medications for heart failure and your doctor has made sure they are working well for you.Your heart's blood pressure and output measurement are higher than a specific number.Your pulmonary vascular resistance is higher than 3 Wood units.You have been diagnosed with specific heart problems related to the right side of your heart.You have severe heart failure that meets specific criteria, including being unable to walk due to heart failure or having a very low body mass index and a specific measure of heart function.You have long-term kidney problems that need dialysis or have a specific level of kidney function.You need to meet certain heart function requirements during exercise while lying down.You have been diagnosed with a specific type of high blood pressure in the lungs due to heart problems, and it has been confirmed by a specific test within the past year.Your mean pulmonary artery pressure is higher than 25 mmHg.You need to meet certain blood flow criteria during exercise while lying down.
- Group 1: Rivet Shunt Therapy
- 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
How many participants are actively engaged in this trial?
"Affirmative, as indicated by clinicaltrials.gov, this study is actively searching for potential participants. It was initiated on May 10th 2022 and the most recent update occurred on September 26th 2022 with a target of 25 patients at two different research centers."
Is enrollment for this medical experiment still open?
"At present, clinicaltrials.gov data verifies that this medical experiment is actively pursuing patients. The initial posting was on May 10th 2022 and the last time it was updated was September 26th of the same year."
What is the ultimate purpose of this clinical trial?
"According to the trial sponsor, NXT Biomedical, the primary goal of this research is to determine Rate of Technical Success of the Rivet Shunt Implantation Procedure over a one-month span. Additionally, secondary endpoints such as Change in Hemodynamics at 12 months - mPAP/CO Slope (mean pulmonary artery pressure/cardiac output slope), Change in RV Chamber Size at 12 months - Diameter, and Adverse Events through 12 months will be measured throughout this clinical study period."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger