Portico™ NG (Navitor) Valve and FlexNav™ Delivery System for Aortic Valve Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intermountain St. George Regional Hospital, Saint George, UT
Aortic Valve Stenosis+2 More
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new type of heart valve may be safe and effective for patients with aortic stenosis.

See full description

Eligible Conditions

  • Aortic Valve Stenosis
  • Symptomatic Severe Aortic Stenosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Aortic Valve Stenosis

Study Objectives

This trial is evaluating whether Portico™ NG (Navitor) Valve and FlexNav™ Delivery System will improve 2 primary outcomes and 1 secondary outcome in patients with Aortic Valve Stenosis. Measurement will happen over the course of at 30 days.

at 30 days
Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications
Primary effectiveness endpoint is moderate or greater paravalvular leak
Primary safety endpoint is all-cause mortality

Trial Safety

Safety Progress

1 of 3

Other trials for Aortic Valve Stenosis

Trial Design

2 Treatment Groups

Portico™ NG (Navitor) valve, FlexNav™ Delivery System
1 of 2
Navitor Titan Valve
1 of 2
Experimental Treatment

This trial requires 399 total participants across 2 different treatment groups

This trial involves 2 different treatments. Portico™ NG (Navitor) Valve And FlexNav™ Delivery System is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Portico™ NG (Navitor) valve, FlexNav™ Delivery System
Device
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Navitor Titan Valve
Device
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 30 days for reporting.

Closest Location

Intermountain St. George Regional Hospital - Saint George, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent).
Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.
Aortic annulus diameter of 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)
Key

Patient Q&A Section

What are the latest developments in portico™ ng (navitor) valve and flexnav™ delivery system for therapeutic use?

"The portico valves continue to advance with improved efficacy. Flexnav valve has also shown superiority at higher left ventricular pressures, especially in patients with low EF." - Anonymous Online Contributor

Unverified Answer

Can aortic valve stenosis be cured?

"Even if aortic stenosis has become asymptomatic, it is still a medical emergency and is still associated with a relatively high risk of death. Surgical treatment should be recommended to prevent further complications." - Anonymous Online Contributor

Unverified Answer

What is aortic valve stenosis?

"AS and aortic insufficiency are both associated with an increased risk for stroke. AS in women, particularly those older than 60 y at presentation, is associated with an increased risk for stroke. AS may occur with aortic insufficiency. In women, concomitant aortic insufficiency with severe pulmonary valve stenosis is associated with an almost 30% risk of stroke, while concomitant severe pulmonary stenosis with severe aortic insufficiency only has a 12% risk of stroke." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aortic valve stenosis?

"The common treatments for mitral and/or aortic valvular stenosis are similar in the management of patients. Aortic valve replacement is now performed in most patients. However, the timing of surgery in those with comorbid mitral stenosis remains unclear. Surgery should be performed at the time when the patient is symptomatic, as long-term risk is high." - Anonymous Online Contributor

Unverified Answer

What causes aortic valve stenosis?

"Though the causes are likely multifactorial, a genetic component to BAVS is considered likely and further investigation is warranted. Aortic valve stenosis is more common in women than in men, suggesting that women are more susceptible to this condition than men. There is an association between BAVS and hypertension, which may have a genetic basis." - Anonymous Online Contributor

Unverified Answer

What are the signs of aortic valve stenosis?

"Aortic stenosis can be suspected on the clinician's basis only in the presence of heart murmurs that are of a pulsus type and in the absence of other features, i.e., syncope in young males with high-powered cardiac murmur. Echocardiography is the most important tool for diagnosing aortic stenosis and evaluating the severity of AS on a clinical basis; however, blood pressure and murmur intensity should also be examined. There are many symptoms and signs of aortic stenosis and if they are not present, it may be difficult to diagnose the disease solely on the basis of history and physical examination alone." - Anonymous Online Contributor

Unverified Answer

How many people get aortic valve stenosis a year in the United States?

"Patients who have aortic stenosis are likely to be older, female, and of lower socioeconomic status than patients with coronary artery disease. As the number of patients with aortic stenosis increases, the number of patients with severe coronary artery disease may suffer a decrease. The National Heart, Lung and Blood Institute's criteria may represent a compromise among different stakeholders." - Anonymous Online Contributor

Unverified Answer

Is portico™ ng (navitor) valve and flexnav™ delivery system typically used in combination with any other treatments?

"In our study, combined use of n-ng valve with other procedures for patients with severe aortic stenosis did not achieve better results than either valve alone. Based on our findings, if a patient is planned to receive only one valve, we recommend that a non-valved device be reserved for this patient population." - Anonymous Online Contributor

Unverified Answer

Has portico™ ng (navitor) valve and flexnav™ delivery system proven to be more effective than a placebo?

"As a transcatheter closure device, with which are you more likely to find yourself, the NaviceSpring Flexnav DS and the Portico Navice NT and Ng (naviter) valve appear effective, and have demonstrated excellent or very good results in small randomized clinical studies. These devices have been adequately validated through comparative studies, large-scale observational studies, and large randomized placebo-controlled studies. In summary, the devices and devices were effective in improving clinical outcomes and were associated with low rates of serious endoleaks. The devices offer a valid alternative to surgical aortic valve replacement and can therefore provide a favorable alternative for patients who otherwise would not be eligible for aortic valve replacement." - Anonymous Online Contributor

Unverified Answer

Is portico™ ng (navitor) valve and flexnav™ delivery system safe for people?

"Our report is the first to describe the safety of portico™ ng (navitor) valve and flexnav™ delivery system in 5 patients, and highlights possible hazards of both devices." - Anonymous Online Contributor

Unverified Answer

How does portico™ ng (navitor) valve and flexnav™ delivery system work?

"The outcomes of the authors' experience with the Portico™ NG / Flexnav™ delivery device in valve-in-valve patients with bicuspid aortic valve disease are very favorable. The authors' findings support the need for large-scale validation of this strategy for aortic valve implantation with bicuspid aortic valve disease." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of portico™ ng (navitor) valve and flexnav™ delivery system?

"The most common side effects were related to the device type that was used. Results from a recent clinical trial is unique in its use of the Portico MVS system. To the best of our knowledge, there are no reports of use of this system with a non-inferior mitral valve, [even though most patients in the Portico group are on long-term warfarin treatment] in humans. The Portico System should be used in patients with mitral stenosis undergoing surgical valve replacements. However, patients receiving this device could be instructed to take all medicines regularly, such as warfarin." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Aortic Valve Stenosis by sharing your contact details with the study coordinator.