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Pulmonary Artery Shunt
Rivet Shunt for Pulmonary Hypertension with Heart Failure
N/A
Waitlist Available
Research Sponsored by NXT Biomedical
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 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment called Rivet PVS therapy to see if it is safe and effective. It focuses on patients who have high blood pressure in their lungs that causes symptoms. The goal is to find out if this new therapy can help reduce their symptoms.
Eligible Conditions
- Heart Failure
- Pulmonary Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Major Adverse Events
Rate of Technical Success of the Rivet Shunt Implantation Procedure
Secondary study objectives
Adverse Events through 12 months
Change in Hemodynamics at 12 months - PCWP
Change in Hemodynamics at 12 months - mPAP/CO Slope
+3 moreAwards & 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: Rivet Shunt TherapyExperimental Treatment1 Intervention
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Who is running the clinical trial?
NXT BiomedicalLead Sponsor
1 Previous Clinical Trials
1 Trials studying Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Rivet Shunt Therapy
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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