Portico transcatheter aortic valve for Aortic Valve Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington Hospital Center, Washington, United States
Aortic Valve Stenosis
Portico transcatheter aortic valve - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new heart valve may help treat aortic stenosis.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Portico transcatheter aortic valve will improve 3 primary outcomes and 6 secondary outcomes in patients with Aortic Valve Stenosis. Measurement will happen over the course of 30 days from index procedure.

Day 30
Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)
30 days from randomization
Primary Safety Endpoint (Randomized IDE Cohort)
One year
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)
Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)
Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)
One year from index procedure
Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry)
One-year from randomization
Primary Effectiveness Endpoint (Randomized IDE Cohort)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Randomized IDE Cohort, CAV
1 of 4
Nested Valve-in-Valve Registry
1 of 4
Randomized IDE Cohort, Portico Valve
1 of 4
FlexNav Delivery System Study
1 of 4
Active Control
Experimental Treatment

This trial requires 1150 total participants across 4 different treatment groups

This trial involves 4 different treatments. Portico Transcatheter Aortic Valve is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Nested Valve-in-Valve Registry
Device
Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve Status: ACTIVE, ENROLLING.
Randomized IDE Cohort, Portico Valve
Device
Portico transcatheter aortic valve and Portico delivery system. Status: ACTIVE, NOT ENROLLING.
FlexNav Delivery System Study
Device
Portico transcatheter aortic valve and FlexNav delivery system Status: ACTIVE, NOT ENROLLING
Randomized IDE Cohort, CAV
Device
Any FDA approved, commercially-available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING.

Trial Logistics

Trial Timeline

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

Closest Location

Washington Hospital Center - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Subject is 21 years of age or older at the time of consent.
Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association (NYHA) Functional Classification of II, III, or IV.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5, 6, 7 of the above criteria,
The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in these patients.
Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography (CT) conducted within 12 months prior to informed consent. Note: if CT is contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject selection committee.
Subject has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2 (indexed effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).
Subjects must have co-morbidities such that the surgeon and cardiologist Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a minimum Society of Thoracic Surgeons (STS) score of 8%. A candidate who does not meet the STS score criteria of ≥ 8% can be included in the study if a peer review by at least two surgeons concludes and documents that the patient's predicted risk of operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not captured by the STS score must be documented in the study case report form as well as in the patient medical record.

Patient Q&A Section

What is aortic valve stenosis?

"Individuals with aortic stenosis may have sudden abnormal heart sounds, dizziness, and orthopnea. Complications can include aortic dissection, pulmonary embolism, and cardiac arrest. Severe aortic stenosis can affect one or more heart valves and often affects the aortic valve only. The aortic valve, being small and complex, is the most affected of all valves. Individuals with aortic stenosis should be evaluated for their risk of heart valve disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of aortic valve stenosis?

"Aortic stenosis is the most common valvular disease in the community. There are significant and varied symptoms that can manifest as patients with aortic stenosis seek medical attention. Physicians must be aware of aortic stenosis presentations when evaluating patients with different symptoms, especially in the elderly and for individuals that have an atypical chest pain. To identify the initial presentation of aortic stenosis, the [Chest Pain Society Guidelines for Aortic Stenosis] are summarized in this article. A detailed medical history and physical examination and specific laboratory tests can help to establish whether aortic stenosis or another diagnosis is more likely. Further evaluation may involve echocardiography." - Anonymous Online Contributor

Unverified Answer

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

"The high prevalence of aortic stenosis in United States population and lower rate of surgical repair indicates the need for improved access to timely surgical treatment of aortic stenosis." - Anonymous Online Contributor

Unverified Answer

Can aortic valve stenosis be cured?

"The data from this study do not support the view that valve surgery can cure aortic stenosis. Although symptomatic improvement may be achieved in the majority of treated patients and this is a good indication in these patients, one-third of these patients will have a recurrence of symptoms within 5 years. These patients will have to be followed up regularly." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aortic valve stenosis?

"The most common treatment for aortic stenosis is cardiovascular replacement surgery. A variety of techniques such as the Ross operation, Ross-Konno, and St. Jude-DeBakey valve replacement procedures are used. However, valve replacement surgery is highly dependent on patient age, comorbidities, and other patient and surgeon specific factors. Although no cure is evident, valvular heart disease is highly treatable." - Anonymous Online Contributor

Unverified Answer

What causes aortic valve stenosis?

"Besides its usual congenital cause, aortic stenosis is multifactorial. Its aetiology is largely unknown in patients ≤ 50 years of age; however, the increase in patients ≥ the age of 50 years causes an increase in the aetiology of aortic stenosis. Moreover, the increase in the number of patients with aortic stenosis was explained by an increase in congenital aortic stenosis, but also by the increase in the number of patients who develop this disease after the age of 50 years." - Anonymous Online Contributor

Unverified Answer

Is portico transcatheter aortic valve typically used in combination with any other treatments?

"In a recent study, findings suggest that the use of TAV in patients with AVS is rare in the United States. The current guidelines for TAV are mostly focused on patients with severe AS who are expected to have profound valve obstruction and to receive high-risk surgical therapy. There is a paucity in our database of patients treated with TAV in combination with other treatments." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of portico transcatheter aortic valve?

"The most common complications were minor, and were not considered serious by the patients. The most common side effects were local bleeding, transient ischemic attacks, and minor neurologic disturbances." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for aortic valve stenosis?

"In this cohort of aortic stenosis patients from a United Kingdom center, the proportion receiving a clinical trial was low (15%). Most patients received conservative management and did not meet criteria for a formal randomized trial, but some patients were excluded from clinical trials, particularly those who were underweight or who were younger and/or had no concomitant risk factor. These conclusions are limited if they are transferable to other centers or countries. Further studies are required to identify and resolve specific barriers to clinical trial participation." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of aortic valve stenosis?

"The primary cause of aortic valve stenosis is thought to be a structural abnormality (such as thickening) of valvular interstitial tissue, rather than a change of cardiac function (as may be the case with aortic regurgitation)." - Anonymous Online Contributor

Unverified Answer

Has portico transcatheter aortic valve proven to be more effective than a placebo?

"In the TIPS-PTAVS comparison, the study results indicate a reduction of TTRs and an improvement of the NYHA functional class. In our study, the authors found a significant decrease of the number of endovascular interventions and procedural length." - Anonymous Online Contributor

Unverified Answer

What is the latest research for aortic valve stenosis?

"Although research results have become more frequent lately, there are still some doubts regarding the validity of some of these trials. Patients with bioprosthetic aortic valves should be followed up with regular echocardiograms and they should receive additional preventive therapies, and aortic valve stenosis should be considered in the list of indications for surgery." - 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.
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