Treatment of Heart Failure and Mitral Valve Regurgitation (backflow of blood in the heart) With the Experimental MVRx Arto System

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"This study will assess the safety and function of a new mitral valve repair system called the Arto System."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: mitral valve, mitral valve repair
Type: Device study
Target:
5 Participants
Investigator:
Description
We invite you to take part in a research study because you have a condition called mitral regurgitation. This is a condition in which blood flows through the mitral valve in the incorrect direction during part of the cardiac cycle. The type of mitral regurgitation you have is called functional. It is caused by widening of the mitral valve opening. As the opening widens the valve leaflets no longer close as they should and blood leaks or regurgitates in the wrong direction.

The preferred treatment of functional mitral regurgitation has not been definitively established. Your doctors have determined that, although you are healthy enough to undergo open heart surgery, it is not the best option for you. You may benefit from a new mitral valve repair system. This system uses catheters (transcatheter) to repair the valve instead of open heart surgery. This is an early feasibility research study to test the safety and performance for a new transcatheter mitral valve repair system.

The safety and effectiveness of this device and therapy option have not been determined. You will be among the first patients in the world to be treated with this device. The purpose of this consent form is to help you decide if you want to be in the research study.

The goal of this study is to assess the safety and function of a new mitral valve repair system called the Arto System. It will be used in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).

The study device is called the MVRx Arto system. The device consists of two parts: a delivery system and a permanent implant which stays in your heart after the procedure. The delivery system enables the doctor to get the implant to the left atrium of the heart. (The atria are the upper chambers of the heart). The permanent implant device is made up of a bridge with two anchors, one at each end of the bridge. The anchors hold the device in place by attaching into the wall of the heart. The bridge is then tightened to help the valve leaflets close tightly together and therefore helps reduce the flow of blood in the wrong direction.
This study requires

If you decide to take part in the Trial, you will then have some tests and procedures as described below.

Screening (before you are enrolled) You will undergo the following tests and procedures to determine if you qualify for entry into the study.

  • Your medical history will be reviewed with you including your medication history.

  • You will be given a physical examination (a clinical evaluation of your condition), and any findings will be written down in the study chart.

  • Your heart rate, blood pressure, temperature, height and your weight will be obtained.

  • An ECG (sticky pads will be placed on your chest to measure the electrical activity of your heart) will be obtained.

  • Transthoracic echocardiogram (TTE: This is where some gel and a probe are placed on your chest to record images of your heart using ultrasound).

  • Your condition will be graded based on your ability to perform physical activities (NYHA class).

  • You will be asked to do a six-minute walk test (a test to see how far you can walk in 6 minutes).

  • You will complete a questionnaire that will help your doctor assess your quality of life.

  • Blood will be collected for laboratory testing. The blood test will consist of a needle being stuck into a vein in your arm (or other area where a vein can be accessed). Approximately 15mls (3 teaspoons) of blood will be taken at this visit for routine tests.

  • A CT scan (diagnostic imaging technique in which a computer reads a series of x-rays to create a three-dimensional map of tissue or bone), angiography (special X-Ray test to evaluate the changes to your heart).

  • If you are a woman of child-bearing age (and are not sterile) a small amount of blood or urine will be obtained to check for pregnancy.

If you do not meet these qualification requirements your participation in the study will be discontinued and you should talk to the study doctor about further treatment for your mitral regurgitation.

If all criteria have been met, and you have agreed to participate in this study by signing this consent, you will be scheduled for your procedure.

Procedure The following procedures and observations will be performed in association with the implant procedure:

  • The expected duration of the entire procedure is about two hours.

  • The valve repair procedure using the investigational device will be carried out under general anesthesia and sedation (you will not be awake) in the cardiac catheterization lab.

  • This is not an open heart procedure. While you are asleep, the valve repair will be performed by making small incisions in the blood vessels in your groin and neck. This will enable your doctor to have access to your arteries and veins and to deliver the device. We will also inject contrast dye into the pumping chamber or your heart.

  • During the procedure you will have a transesophageal echo (TEE). This involves inserting an ultrasound probe into your throat. This echo helps your doctor to accurately position the device.

  • You will receive heparin (a blood thinner) during the procedure to prevent blood clots.

  • After the procedure you will be given anticoagulation (blood thinning) medication (aspirin will be taken for 6 months post procedure and clopidogrel for 3 months).

Post procedure evaluation

  • Transthoracic echocardiogram (TTE: This is where some gel and a probe are placed on your chest to record images of your heart using ultrasound).

  • Blood will be collected for laboratory testing. The blood test will consist of a needle being stuck into a vein in your arm (or other area where a vein can be accessed). Approximately 15mls (3 teaspoons) of blood will be taken for routine tests. The tests are the same as the screening blood draw: CBC (a count of the different types of cells in your blood), CK and CK-MB (markers that reflect damage to the heart), BNP (a peptide that evaluates congestive heart failure), and creatinine serum (a blood test that shows kidney function). .

  • You will be asked if you have experienced any unusual symptoms or side effects since the procedure.

  • We will review which medications you are taking.

Discharge

  • You will be given a physical examination (a clinical evaluation of your condition).

  • Your condition will be graded based on your ability to perform physical activities (NYHA class).

  • Blood will be collected for laboratory testing. The blood test will consist of a needle being stuck into a vein in your arm (or other area where a vein can be accessed). Approximately 5mls (1 teaspoon) of blood will be taken for routine tests.

  • Transthoracic echocardiogram (TTE: This is where some gel and a probe are placed on your chest to record images of your heart using ultrasound).

  • We will review which medications you are taking.

  • You will be asked if you have experienced any unusual symptoms or side effects since the procedure.

Follow-Up If you are enrolled in the study, you will be expected to follow-up with your study doctor periodically. The follow-up time points occur at 30 days, 90 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years after your procedure.

Who can participate

Inclusion criteria:

  1. Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
  2. Age ≥ 18
  3. Trans-septal catheterization is determined to be feasible by the treating physician
  4. NYHA class II-IV heart failure of any etiology
  5. Symptomatic with MR grade ≥ 2+
  6. LVEF ≥20% ≤ 50%
  7. LVEDD > 50 mm and ≤ 70 mm
  8. No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
  9. In the opinion of the investigator and heart surgery team, the patient is not a candidate for surgery, and the use of the ARTO™ System is technically feasible.

Exclusion criteria:

  1. In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
  2. Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
  3. Significant mitral annular calcification
  4. Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
  5. Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
  6. History of, or active, rheumatic heart disease
  7. History of Atrial Septal Defects (ASD), whether repaired or not
  8. History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
  9. In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
  10. Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 5 years.
Recruitment period
From Sept. 23, 2016
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Clinical Trials Office
Research Topic
Conditions:
  • Mitral Valve Regurgitation

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview