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Heart Valve
New Aortic Heart Valves for Aortic Stenosis
N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days
Awards & highlights
Study Summary
This trial is to study the safety and effectiveness of a new aortic heart valve in people who are at high or extreme risk for surgery.
Who is the study for?
This trial is for high or extreme surgical risk patients with symptomatic aortic stenosis, confirmed by specific heart function classifications and measurements. Eligible participants must have an aortic valve area of ≤1.0 cm2 among other criteria, but cannot join if they've had recent heart attacks, certain blood disorders, previous heart valve replacements, or severe mitral valve issues.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the Navitor (Portico™ NG) Transcatheter Aortic Heart Valve in reducing death rates at 30 days post-operation and minimizing paravalvular leaks in patients who are not good candidates for traditional surgery.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include bleeding due to anticoagulation therapy required after implantation, vascular complications from inserting the device through small vessels, stroke risks associated with heart procedures, and possible irregularities in heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms of aortic stenosis and my activity is somewhat to severely limited.
Select...
My heart valve is severely narrowed, confirmed by an echo test within the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary effectiveness endpoint is moderate or greater paravalvular leak
Primary safety endpoint is all-cause mortality
Secondary outcome measures
Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications
Trial Design
2Treatment groups
Experimental Treatment
Group I: Portico™ NG (Navitor) valve, FlexNav™ Delivery SystemExperimental Treatment1 Intervention
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).
Group II: Navitor Titan ValveExperimental Treatment1 Intervention
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,855 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a heart attack with ST segment elevation on an ECG within the past 30 days.I have symptoms of aortic stenosis and my activity is somewhat to severely limited.I had a heart or blood vessel procedure through the skin within the last 30 days.I have had a stroke or a mini-stroke in the last 6 months.The blood vessels in the access area are too small for the delivery system to be used.My heart valve condition mainly involves severe leakage.I haven't had a stomach ulcer or upper GI bleeding in the last 3 months.I do not have severe blood disorders or a history of bleeding problems.My heart valve is severely narrowed, confirmed by an echo test within the last 3 months.I have a heart valve implant or severe heart valve issues.Your aortic annulus and ascending aorta are within a certain size range as measured by a CT scan for the specified valve size.You have a higher risk of complications from aortic valve surgery due to frailty or other health issues, as determined by a heart team or a specific risk score.
Research Study Groups:
This trial has the following groups:- Group 1: Portico™ NG (Navitor) valve, FlexNav™ Delivery System
- Group 2: Navitor Titan Valve
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 research currently enrolling participants?
"Affirmative. The information on clinicaltrials.gov verifies that this experiment is still open for enrollment, having initially been posted in September of 2019 and last updated October 18th 2022. 399 participants are required at the 15 participating locations."
Answered by AI
Who meets the eligibility criteria to take part in this research?
"In order to be eligible for this clinical trial, participants must have been diagnosed with aortic valve stenosis and fall within the age range of 18-100. Currently 399 individuals are being enrolled in this study."
Answered by AI
Does this experimental research extend to participants aged 55 or older?
"According to the study's requirements, individuals aged 18 and above, who do not exceed 100 years of age are eligible for participation."
Answered by AI
In what areas of the state are there medical facilities conducting this clinical research?
"Currently, this clinical trial is available in 15 locations, including Albany, Morristown and New york City. It may be advantageous to choose the nearest site if you are interested in enrolling so as to minimize transportation costs."
Answered by AI
To what extent is participation being sought for this research?
"This medical trial necessitates 399 qualified patients. Those enrolled may come from locations such as the Albany Medical Center in Albany, New york or Atlantic Health Morristown Memorial Hospital in Morristown, New jersey."
Answered by AI
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