What side effects are associated with this type of intervention?

The most common treatments for aortic valve stenosis include surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). TAVR, which is similar to the Portico Transcatheter Heart Valve system, is less invasive and is often used for high-risk patients. Known side effects of TAVR include vascular complications, bleeding, stroke, and the potential need for a permanent pacemaker. Other risks include paravalvular leak, kidney injury, and infection. SAVR, while effective, carries risks such as longer recovery time, infection, bleeding, and complications related to anesthesia.

What prior FDA approvals exist?

The FDA has approved several transcatheter aortic valve replacement (TAVR) devices for the treatment of severe symptomatic aortic valve stenosis, particularly in patients who are at high or extreme risk for surgical valve replacement. These devices include the Edwards SAPIEN valve and the Medtronic CoreValve, among others. These approvals are based on extensive clinical trial data demonstrating their safety and efficacy in improving blood flow and reducing symptoms in affected patients.

What other types of research exist?

Promising novel alternatives to the Portico Transcatheter Heart Valve for aortic valve stenosis patients include the Edwards SAPIEN 3 Ultra and the Medtronic Evolut PRO+ systems. These devices have demonstrated advancements in valve design, delivery systems, and procedural outcomes, offering improved safety and efficacy for high-risk patients.

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Transcatheter Aortic Valve

Portico Valve for Aortic Stenosis (PORTICO-IDE Trial)

Q: What is the mechanism of action of this treatment?

Aortic valve stenosis is commonly treated through surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). SAVR involves open-heart surgery to replace the diseased valve with a mechanical or biological prosthetic valve, which improves blood flow and reduces symptoms by eliminating the obstruction. TAVR, a less invasive alternative, involves threading a catheter through the blood vessels to implant a new valve within the diseased aortic valve. This method is particularly beneficial for high-risk patients who may not be suitable candidates for open-heart surgery. Both treatments aim to restore normal valve function, thereby improving cardiac output and alleviating symptoms such as shortness of breath, chest pain, and fatigue, which are critical for enhancing the quality of life and survival in patients with severe aortic stenosis.

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

Must not have

Subject's access vessel (subclavian/axillary) has a distance between the annular plane and the integrated sheath distal tip <17 cm (6.7")

Active bacterial endocarditis within 6 months prior to the index procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new heart valve replacement device for patients with severe heart valve issues who are too high-risk for traditional surgery. The device is inserted through a blood vessel, making the procedure less invasive.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have symptoms of aortic stenosis and my activity is somewhat to severely limited.

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood vessel near the shoulder is less than 6.7 inches from a specific point.

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I have not had a serious heart infection in the last 6 months.

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My heart valve is thickened and near the artery openings.

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My aorta is heavily calcified, making certain heart procedures complicated.

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I have a thickened heart muscle, with or without blockage.

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I have severe kidney problems or am on long-term dialysis.

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I do not have major aortic disease like large aneurysms or severe artery twists.

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I have a history of heart bypass surgery that may affect treatment access.

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I have a heart valve implant or severe heart valve issues.

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I have a history of bleeding or clotting disorders.

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I have severe heart failure requiring medication or mechanical support.

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I have a heart condition that hasn't been treated but needs surgery.

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I need emergency surgery.

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My heart's pumping ability is severely reduced.

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My blood vessels in the hip area are not severely blocked or twisted, making it safe for certain medical procedures.

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My aortic valve is either congenital unicuspid, bicuspid, or non-calcified.

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I need medication or a device to help my heart pump blood.

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I have severe aortic valve disease with more leakage than narrowing.

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My heart's aortic opening is either smaller than 19 mm or larger than 27 mm.

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I have a condition that makes heart access through the chest difficult.

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My arteries near the shoulder are very narrow or twisted.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one-year from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one-year from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and one-year from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aortic valve stenosis is commonly treated through surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). SAVR involves open-heart surgery to replace the diseased valve with a mechanical or biological prosthetic valve, which improves blood flow and reduces symptoms by eliminating the obstruction. TAVR, a less invasive alternative, involves threading a catheter through the blood vessels to implant a new valve within the diseased aortic valve. This method is particularly beneficial for high-risk patients who may not be suitable candidates for open-heart surgery. Both treatments aim to restore normal valve function, thereby improving cardiac output and alleviating symptoms such as shortness of breath, chest pain, and fatigue, which are critical for enhancing the quality of life and survival in patients with severe aortic stenosis.

Transcatheter aortic valve replacement in low risk patients.Medical Treatment of Aortic Stenosis.Transcatheter aortic valve replacement.