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Pulmonary Artery Shunt
Rivet PVS Therapy for Pulmonary Hypertension and 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
Prior diagnosis of Group 2 PH due to HFpEF, with confirmed resting hemodynamic criteria by right heart catheterization
Chronic symptomatic heart failure documented by NYHA HF Class II with history > II, or Class III, or ambulatory Class IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is evaluating a new therapy for pulmonary hypertension and testing how well it works and how safe it is.
Who is the study for?
This trial is for adults with heart failure and pulmonary hypertension who've been hospitalized or have high NT-pro BNP levels. They must have a history of symptoms, be able to walk at least 100 meters, and be on stable heart medication. People with severe kidney issues, other types of pulmonary hypertension, significant right ventricular dysfunction, extreme blood pressure in the lungs, or severe heart failure are not eligible.Check my eligibility
What is being tested?
The Rivet PVS therapy is being tested for safety and effectiveness in treating patients with symptomatic pulmonary hypertension due to left heart disease (Group 2 PH-HFpEF). This early study involves multiple centers where participants will receive the new treatment without being compared to a control group.See study design
What are the potential side effects?
While specific side effects are not listed here, interventions like the Rivet Shunt may cause complications such as irregular heartbeat, bleeding, infection risk from the procedure itself or device-related problems that could affect lung or heart function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of high blood pressure in the lungs due to heart failure.
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I have chronic heart failure that affects my daily activities.
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I have been hospitalized for heart failure or needed strong diuretics recently.
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I am 18 years old or older.
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I can walk 100 meters or more without stopping.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Major Adverse Events
Rate of Technical Success of the Rivet Shunt Implantation Procedure
Secondary outcome measures
Adverse Events through 12 months
Change in Hemodynamics at 12 months - PCWP
Change in Kansas City Cardiomyopathy Questionnaire
+1 moreTrial 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
25 Total Patients Enrolled
1 Trials studying Heart Failure
25 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a specific type of high blood pressure in the lungs due to heart failure.I have chronic heart failure that affects my daily activities.I need home oxygen, was hospitalized for lung issues recently, or have low lung function.I have not had any heart-related treatments in the last 30 days.Your mean RAP (right atrial pressure) is higher than 16 mmHg during a resting test.I have severe heart failure and may need a heart transplant.My heart's right ventricle is not functioning properly.My heart failure treatment is stable and won't change for a month.I have been hospitalized for heart failure or needed strong diuretics recently.My kidney function is low, with an eGFR under 35.You have a specific type of pulmonary hypertension.I am 18 years old or older.I can walk 100 meters or more without stopping.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently recruiting participants?
"The clinical trial in question is no longer recruiting, as per the data found on clinicialtrials.gov. It was initially posted to the website on October 1st 2022 and its most recent update happened September 26th of that year; however, 1431 other active trials are seeking participants at this time."
Answered by AI
What is the primary objective of this clinical experiment?
"This month-long experiment seeks to assess the Technical Success Rate of Rivet Shunt Implantation Procedure. Auxiliary objectives feature an examination of Change in Hemodynamics at 12 months - PCWP (Change in exercise pulmonary capillary wedge pressure from baseline), Change in Kansas City Cardiomyopathy Questionnaire, and Change in RV Chamber Size at 12 months - Diameter (Change in RV Chamber Size assessed by a core lab between baseline and 12 months)."
Answered by AI
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