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Patient information

If you have aortic stenosis, you may be eligible for the
ENVISION Clinical Trial

Patient information

If you have aortic stenosis, you may be eligible for the
ENVISION Clinical Trial

The ENVISION Clinical Trial is studying the Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System in patients with severe, symptomatic aortic stenosis who are deemed low or intermediate surgical risk. 

Approximately 1,500 patients will be studied at up to 80 medical centers in the United States and up to 15 medical centers outside of the United States. A qualified team of doctors will monitor the patients included in the ENVISION Clinical Trial. 

Clinical trial participants will play an important role in helping doctors evaluate the use of the Navitor TAVI System for patients with severe aortic stenosis. 

NCT05932615 ClinicalTrials.gov

 

On the left side of the heart, blood flows through the left ventricle into the aorta through the aortic valve. Severe aortic stenosis is a condition in which the aortic valve leaflets become thick or stiff, reducing their ability to fully open and close. This narrowing of the valve makes your heart muscle work harder to deliver oxygen-rich blood to the brain and the rest of your body.

 

Aortic stenosis is one of the most common valve diseases and usually develops later in life.

Causes include:

  • Buildup of calcium on the valve
  • Infection of the heart
  • Birth defects
  • Rheumatic fever
  • Radiation therapy

The symptoms of aortic stenosis are commonly misunderstood by patients as “normal” signs of aging. Symptoms of aortic stenosis include, but are not limited to:

Shortness of Breath

Trouble breathing

Chest pain

Dizziness

Dizziness, lightheadedness, or even fainting

Fatigue with
normal activities

Difficulty walking short distances

Irregular Heartbeat

Rapid, fluttering heartbeat

Fatigue

Difficulty sleeping

Ankles and Feet swelling

Swollen ankles
or feet

Based on your level of risk, the outcomes from your diagnostic tests and lifestyle preference, your doctor will recommend the best treatment option for you. There are various treatment options for severe aortic stenosis including medication, balloon aortic valvuloplasty, surgical aortic valve replacement or transcatheter aortic valve implantation.

SURGICAL AORTIC VALVE
REPLACEMENT (SAVR)

Aortic valve replacement can be performed using several surgical approaches to open-heart surgery, including traditional sternotomy (with an incision over the chest and sternum), minimally invasive surgery that does not involve opening the chest, and less invasive robotic procedures.

TRANSCATHETER AORTIC VALVE
IMPLANTATION (TAVI)

Transcatheter aortic valve implantation provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis.

STEP 1

Your doctor will determine the best approach for replacing your valve, but the most common approach is the transfemoral approach, described here. A small cut is made in a large artery in your groin and a sheath (access tube) is inserted within your artery. The doctors view the movement of the sheath using special imaging equipment, which guides them to know when the sheath is in the correct position.

STEP 2

Once the sheath is in position, a guiding wire and balloon catheter (thin, flexible tube) with a balloon is delivered through the sheath and placed within your aortic valve. The balloon is inflated to open up your aortic valve as much as possible so that the Navitor™ Valve can be placed inside of it. The balloon catheter is then removed.

STEP 3

The Navitor Valve is delivered with a catheter through the sheath and placed within your opened aortic valve. Your doctor will deploy the valve into the correct positioning using special visualization equipment to ensure the valve is positioned accurately within your heart.

STEP 4

Once the valve is deployed and accurately in place, the Navitor Valve will start to function immediately.

STEP 5

The sheath and catheter are removed from your heart and groin, and the small incision in your groin is closed or sealed. The procedure is now complete.

ARE YOU A CANDIDATE FOR
THE ENVISION CLINICAL TRIAL?

WHO CAN PARTICIPATE IN THE ENVISION CLINICAL TRIAL?


Both men and women can participate. You may qualify if:

  • You have been diagnosed with severe, symptomatic aortic stenosis.
  • It has been determined by your doctor that you are low or intermediate surgical risk and a transcatheter valve is appropriate for you.
     

FIND A TRIAL SITE NEAR ME

WHAT IS INVOLVED IF I CHOOSE TO PARTICIPATE?
 


Before you are enrolled, you will be screened to make sure you are a good candidate for the clinical trial. Your screening may include:

  • An in-person visit with your heart team, which includes the informed consent process.
  • An echocardiogram (ECHO) to determine if you have severe aortic stenosis.
  • A computerized tomography (CT) scan to determine the appropriate valve size.
  • A review of your medical records.
  • Blood tests

You can still see your personal cardiologist for regular checkups and care. In addition, you will be monitored by regular follow-up exams.

WHAT HAPPENS IF I PASS THE SCREENING PROCESS?

 

  1. You will be assessed in person at the treatment center and then registered for the clinical trial.
  2. You will be randomized to either the Navitor™ TAVI System or an alternative, commercially available TAVI system. 
  3. You will have your TAVI procedure.
  4. You will also have in-person or phone call follow-up exams with healthcare providers at 30 days and annually through 10 years.
    • You will have the option to have some of your in-person follow-up visits in the comfort of your own home.

FIND A TRIAL SITE NEAR ME

Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System

The Navitor TAVI System is an FDA approved device to treat patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. The ENVISION Clinical Trial aims to expand the approved use of the Navitor TAVI System to treat patients with symptomatic, severe aortic stenosis who are at intermediate or low surgical risk. In this patient population, the Navitor TAVI System is limited by U.S. law to investigational use only and not for commercial use.

  • Importance of Clinical Research and the ENVISION Clinical Trial
    • The Navitor TAVI System is FDA approved, but currently only for patients at high and extreme surgical risk. The ENVISION trial is evaluating the use of the Navitor TAVI System in patients with symptomatic, severe aortic stenosis who are at intermediate or low surgical risk. The results of this trial may expand availability of the Navitor TAVI System to a new group of patients who are candidates for TAVI.
    • This trial allows doctors to compare treatments (Navitor TAVI System and commercially available TAVI systems) for safety and effectiveness.
    • May help future patients with similar health conditions receive the best treatment.
  • Importance of Diversity in Clinical Trials

    Diversity in clinical trials is critical to represent the real-world population. If applicable (women, minorities), your participation is especially impactful. For more information on the importance of diversity in clinical trials, please visit Clinical Trial Diversity is Key To Future Innovation | Abbott U.S.

FREQUENTLY
ASKED QUESTIONS

  • What will happen if I decide I am interested to take part in this trial?

    This research study includes a screening/qualification phase to determine if you are a good candidate for the study. Your trial doctor or other study personnel will ask you medically related questions. You will undergo testing as part of standard of care for undergoing a transcatheter aortic valve implantation (TAVI) procedure. Additional tests may be conducted to determine if you qualify for the study. Once all screening tests have been completed, your data will be deidentified and sent to an independent committee of experienced doctors who will confirm if you qualify to take part in the study. If the committee decides that you do not qualify for the study, your participation will end.

    If you do qualify, and you decide to take part in this research study, you will return to the clinic for annual follow-up visits over the 10-year follow-up period. You are expected to complete all required follow-up visits. Your local clinical research team will partner with you to schedule follow-up visits alongside your standard of care follow-up visits with your medical care team.

  • Do I have a choice in what TAVI valve I receive to treat my aortic stenosis?

    If qualified for the study, you will not have a choice in what TAVI valve you receive as the ENVISION Clinical Trial is a randomized controlled study.

    Randomization is the process by which you will be randomly (by chance) assigned to either of two groups (control group or treatment group). Like in a coin toss, you will have an equal chance of being assigned to the control group or the treatment group. A computer program will decide to which group you are assigned. The control group will receive an FDA approved TAVI system, and the treatment group will receive the Navitor TAVI system by Abbott. The Navitor TAVI system is already FDA approved for treating your valve condition in patients at high and extreme risk for open-heart surgery. The ENVISION Clinical Trial aims to expand the approved use of the Navitor TAVI system to patients at intermediate and low risk of open-heart surgery.

    You as well as your doctor who performs the TAVI procedure will be aware of your group assignment. Irrespective of the group you are assigned, you will return for visits with your trial doctor following the same schedule.

  • What happens if I am randomized to the control group?

    If you are assigned to the control group, you will undergo a TAVI procedure using a valve that is already FDA approved for patients at intermediate and low risk of open-heart surgery. Your trial doctor will select the appropriate valve for you.

  • What happens if I am randomized to the treatment group?

    If you are assigned to the treatment group, you will undergo a TAVI procedure using the Navitor TAVI system. The Navitor TAVI system is already FDA approved for treating your valve condition in patients at high and extreme risk for open-heart surgery. The ENVISION Clinical Trial aims to expand the approved use of the Navitor TAVI system to patients at intermediate and low risk of open-heart surgery.

  • Where can I learn more about patients who have been treated with the Navitor TAVI system by Abbott?

    You can learn more about the Navitor TAVI system by Abbott at Aortic Valve Replacement

  • Where can I learn more about the ENVISION clinical trial?

    You can learn more about participating in a clinical trial and the ENVISION Clinical Trial at Abbott Structural Heart Clinical Trials.

  • What other choices do I have?

    You will receive available treatment for symptomatic, severe native aortic stenosis whether or not you take part in this trial. If you choose not to take part in this trial, your doctor will treat you according to standard medical care. Your doctor will explain in more detail the various alternative treatment options available to you and the risks and benefits of these alternatives. These treatment options may include:

    1. Implantation of a commercially available TAVI valve for patients at intermediate and low risk of open-heart surgery
    2. Standard open-heart surgery by referral to a heart surgeon. For more information, visit Aortic Valve Replacement

    Your future care and your relationship with your doctor will not be affected if you decide not to be in this trial.

  • Why should I participate in this clinical trial?

    For more information on why to participate in a clinical study, visit Structural Heart's clinical trials page

MAT-2310081 v2.0 | Item approved for U.S. use only.

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FIND A TRIAL SITE NEAR ME
References

ClinicalTrials.gov Identifier: NCT05932615

Important Safety Information
  • Navitor

  • WHAT IS THE NAVITOR™ TAVI SYSTEM APPROVED FOR?
    Available by prescription only.

    Transcatheter Aortic Valve Implantation (TAVI) with the Navitor™ TAVI System provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis, a condition where the aortic valve does not fully open or close, who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky.

    WHO SHOULD NOT RECEIVE TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    You should not receive the Navitor valve if you have any of the following conditions: any kind of infection, including an active infection in the heart; cannot tolerate medication that thins the blood or prevents blood clots from forming; have a reaction or allergy to nitinol, an alloy of nickel and titanium.

    The Navitor™ TAVI System has not been studied in the following patient populations and therefore should not be used in patients who: have any evidence of a blood clot (thrombus), intracardiac mass or vegetation in, on or around the heart; have narrow veins or arteries with calcification that make insertion of the delivery sheath and access to the aortic valve impossible; have stenotic (narrowed) aortic valve without calcium deposits; have a heart valve defect from birth with either one or two leaflets vs. the normal three leaflets; are pregnant or breastfeeding; are age 21 or younger at the time of diagnosis or treatment; have an ejection fraction, or volume of blood fluid, less than 20%; have unstable heart function requiring mechanical assistance or drug therapy to support the normal function of the heart; are low or intermediate surgical risk; have had a previous heart valve or ring in any position in the heart; have mixed aortic valve disease (stenosis and regurgitation); have severe mitral valve disease (calcification, stenosis or inefficiency); have a medical condition that affects the cellular or plasma components of the blood; have significant coronary artery disease that requires treatment; have abnormally thick heart muscle (hypertrophic cardiomyopathy); are on dialysis, have kidney failure or inefficiency; have known allergy or sensitivity to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media/dye; have bulky calcium build up on the valve leaflets close to the coronary ostia which are the main arteries delivering blood from the heart to the rest of the body; have significant aortic disease, including abdominal aorta, thoracic aneurysm or any other folding, bending or narrowing which would make access to the aortic valve impossible.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    There are risks with any heart valve implantation procedure. The most serious risks are: death, stroke, serious damage to the arteries and serious bleeding. Additional risks include, but are not limited to: access site complications (e.g., pain, bleeding, infection, blood vessel damage); buildup of deposits (plaque) in and on the walls of coronary arteries; heart attack - blockage of blood flow to the heart muscle; allergic reaction to medication or products/devices used during the procedure (medication to prevent blood clotting, x-ray die, components of the valve delivery process); tear or burst of the aorta; irregular heart rate; disruption or injury of electrical system in your heart leading to the need for a permenant pacemaker implant; tear or separation of the layers of the wall of an artery; obstruction of an artery, typically by a clot of blood or an air bubble; inflammation of the lining of your heart; failure of your heart to pump enough blood to the body’s organs; unstable blood flow; rupture or destruction of blood cells; blood cell damage; low red blood cell count; bleeding, infection, clotting in or on the valve or tissue of the valve; loose clots in the bloodstream that may block an artery in your arms, legs, or brain; escape of blood from a ruptured blood vessel; blood pressure changes above or below the normal levels; infection; reduced blood flow to your heart, preventing the heart muscle from receiving enough oxygen; changes to the Mitral valve where it doesn’t close tightly; multi-organ failure - inflammation from a severe infection or injury causes dysfunction in two or more organ systems; wrong sizing or positioning of the implanted valve; collection of fluid or blood around your heart; perforation or tear of the heart muscle, ventricle or blood vessel; formation of scar tissue that may cover or block the valve from functioning normally; leakage of blood around the edge of the valve; valves in your heart don’t close tightly, allowing blood to flow backward in your heart; kidneys lose the ability to remove waste and balance fluids; blood doesn’t have enough oxygen or has too much carbon dioxide; sepsis; structural deterioration of the implanted valve (i.e., calcification, leaflet tear); having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve; when extra fluid builds up in the space around the heart; when the transcatheter valve moves or is dislodged from the deployment position/location; permanent disability; the need for additional medical procedures to include blood transfusions, operation to remove the valve, use of a balloon to adjust the valve (valvuloplasty), and catheter insertion into coronary arteries to treat blockages.

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