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Transcatheter Aortic Valve
Portico Valve for Aortic Stenosis (PORTICO-IDE Trial)
N/A
Recruiting
Led By Raj R Makkar, MD
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 New York Heart Association (NYHA) Functional Classification of II, III, or IV
Subject is 21 years of age or older at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
PORTICO-IDE Trial Summary
This trial is testing a new heart valve to see if it is safe and effective in treating aortic stenosis in high and extreme risk patients.
Who is the study for?
This trial is for adults over 21 with severe symptomatic aortic valve stenosis who are at high or extreme risk for surgery, as determined by specific health criteria and consultations. Participants must be able to attend follow-up visits, have certain heart function classifications (NYHA II-IV), and an aortic annulus size of 19-27mm. Exclusions include recent heart attacks, certain valve abnormalities, blood disorders, uncontrolled coronary artery disease, kidney failure on dialysis, active infections within the past six months, life expectancy less than one year due to other diseases.Check my eligibility
What is being tested?
The PORTICO trial tests the safety and effectiveness of the St Jude Medical Portico Transcatheter Heart Valve in patients with severe aortic stenosis who are not good candidates for traditional surgery. The study compares this new device against commercially available transcatheter valves using transfemoral (through the leg) and alternative delivery methods.See study design
What are the potential side effects?
Potential side effects may include bleeding complications due to anti-clotting medications used during the procedure; vascular complications from inserting devices into blood vessels; irregular heartbeats; stroke; infection risks associated with any invasive procedure; damage to surrounding structures like arteries or ventricles.
PORTICO-IDE Trial 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...
I am 21 years old or older.
PORTICO-IDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)
Primary Effectiveness Endpoint (Randomized IDE Cohort)
Primary Safety Endpoint (Randomized IDE Cohort)
Secondary outcome measures
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)
Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry)
Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)
+3 morePORTICO-IDE Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Randomized IDE Cohort, Portico ValveExperimental Treatment1 Intervention
Portico transcatheter aortic valve and Portico delivery system.
Status: ACTIVE, NOT ENROLLING.
Group II: Nested Valve-in-Valve RegistryExperimental Treatment1 Intervention
Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve
Status: ACTIVE, ENROLLING.
Group III: FlexNav Delivery System StudyExperimental Treatment1 Intervention
Portico transcatheter aortic valve and FlexNav delivery system
Status: ACTIVE, NOT ENROLLING
Group IV: Randomized IDE Cohort, CAVActive Control1 Intervention
Any FDA approved, commercially-available transcatheter aortic valve (CAV).
Status: ACTIVE, NOT ENROLLING.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,346 Total Patients Enrolled
22 Trials studying Aortic Valve Stenosis
8,070 Patients Enrolled for Aortic Valve Stenosis
Raj R Makkar, MDPrincipal InvestigatorCedars-Sinai Medical Center
Gregory P Fontana, MDPrincipal InvestigatorLos Robles Regional Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart bypass surgery that may affect treatment access.I have a heart valve implant or severe heart valve issues.I have severe heart failure requiring medication or mechanical support.My heart's pumping ability is severely reduced.I have a heart condition that hasn't been treated but needs surgery.My blood vessels in the hip area are not severely blocked or twisted, making it safe for certain medical procedures.Doctors agree surgery is too risky for me due to high chances of death or serious harm.I have severe aortic valve stenosis confirmed by an echo test within the last 60 days.I have symptoms of aortic stenosis and my activity is somewhat to severely limited.I'm sorry, but it seems like the criterion you provided is incomplete. Can you please provide more context or information so that I can accurately summarize the criterion for you?My blood vessel near the shoulder is less than 6.7 inches from a specific point.The procedure requires using a different tube to reach the blood vessel.I have not had a serious heart infection in the last 6 months.My heart valve is thickened and near the artery openings.My aorta is heavily calcified, making certain heart procedures complicated.You have very low levels of white blood cells, red blood cells, or platelets in your blood.I have a thickened heart muscle, with or without blockage.You are allergic to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or have a sensitivity to contrast dye that cannot be managed with medication.I have had a stroke or a mini-stroke in the last 6 months.I have severe kidney problems or am on long-term dialysis.I do not have major aortic disease like large aneurysms or severe artery twists.The angle of the right subclavian or right axillary vein is more than 30 degrees.I have had a heart or blood vessel procedure in the last 30 days.I have a history of bleeding or clotting disorders.I need emergency surgery.My aortic root angle is over 70°, and I am a transfemoral patient.The distance between two specific parts in the body is less than 6 cm (2.4 inches).The blood vessel in your arm is too narrow for the medical equipment needed for the study.You have other health issues that make surgery too risky, with a high chance of not surviving the operation.The angle of the left subclavian or left axillary artery is more than 70 degrees.My aortic valve is either congenital unicuspid, bicuspid, or non-calcified.You had a heart attack within the last 30 days.You have signs of a mass, blood clot, or infection in your heart detected by an ultrasound.Your doctor thinks you might not live for more than a year because of other health problems not related to your heart.I need medication or a device to help my heart pump blood.You have a previously implanted RIMA graft that would make it difficult to access for this study.The distance between two specific points in the body is less than 2.8 inches.I have severe aortic valve disease with more leakage than narrowing.I am 21 years old or older.Your aortic annulus (a part of your heart) is between 19-27mm in size, as measured by a special x-ray scan called a computerized tomography (CT) within the last 12 months before you agree to join the study. If you can't have a CT scan, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted, but it needs approval from the subject selection committee.Your aortic annulus does not have calcium deposits.My heart's aortic opening is either smaller than 19 mm or larger than 27 mm.I haven't had a stomach ulcer or upper GI bleeding in the last 3 months.I have a condition that makes heart access through the chest difficult.My arteries near the shoulder are very narrow or twisted.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized IDE Cohort, Portico Valve
- Group 2: Randomized IDE Cohort, CAV
- Group 3: Nested Valve-in-Valve Registry
- Group 4: FlexNav Delivery System Study
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.
What purpose does this trial seek to accomplish?
"The main outcome of this trial, assessed over a 30-day period from the initiation of randomization, is the percentage of patients with major vascular complications (the primary safety endpoint). Secondary outcomes include the severity and prevalence of severe aortic regurgitation at one year; Kansas City Cardiomyopathy Questionnaire scores at one year on an 0 to 100 scale where higher numbers indicate better symptoms/physical functioning; and six minute walk test results for total distance walked."
Answered by AI
Are there any available openings in this experiment for participants?
"Affirmative, data on clinicaltrials.gov indicates that recruitment for this trial is ongoing. It was initially posted on May 1st 2014 and last updated April 12th 2022, with 1150 patients needed from 16 locations."
Answered by AI
How many sites are currently overseeing this research trial?
"Ohio State University in Columbus, Ohio, Cardiovascular Research Institute of Kansas in Wichita, Kansas and Winthrop University Hospital in Mineola New york are only a few sites amongst 16 others participating this clinical trial."
Answered by AI
What is the sample size of individuals involved in this medical experiment?
"The trial sponsor, Abbott Medical Devices, need 1150 eligible patients to conduct the study. To this end, they are recruiting from locations such as Ohio State University in Columbus and Cardiovascular Research Institute of Kansas in Wichita."
Answered by AI
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