Important Safety Information INTREPID™ TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

Warnings and Precautions

CAUTION: The Intrepid™ Transcatheter Mitral Valve Replacement System is an investigational device. Limited by federal (United States) law to investigational use. Exclusively for clinical investigations. Not approved by FDA and not for sale in the United States.

Important Safety Information

There are risks for participants in this trial. The potential risks associated with the investigational transcatheter mitral valve replacement (TMVR) procedure are similar to the risks of mitral valve surgery, repair and replacement. These potential risks may include, but are not limited to, the following:

  • Death
  • Damage to the heart or its blood vessels (resulting in rips, tears, spasms, or blockages that could possibly require emergency surgery)
  • Disruption of heart rhythm or conduction system
  • Aortic valve dysfunction (the aortic valve is another valve in your heart)
  • Heart attack and/or chest pain
  • Reduced heart function or continuing or worsening heart failure
  • Stroke or mini-stroke (transient ischemic attack called a TIA)
  • Brain damage or deficit
  • Kidney failure or dysfunction (possibly requiring dialysis)
  • Lung or breathing complications (e.g., congestion, pneumonia, respiratory failure)
  • Surgical incision site complications (e.g., infection, bleeding, pain, poor healing)
  • Bleeding (possibly requiring a transfusion or other intervention)
  • Dislodgement of blood clots or air bubbles that block a blood vessel
  • Infection at skin incision sites, within the heart, throughout the body
  • Infection of the inner lining of the heart and the heart valves
  • Viral infection (e.g., Mad Cow Disease) from cow tissue in the implant valve
  • Blood abnormality (e.g. anemia, breakdown of red blood cells)
  • Allergic reaction or reaction to a drug used during the implant procedure
  • Adverse (harmful) events related to administration of a contrast agent (a substance used to increase the contrast of structures or fluids within the body in medical imaging)
    • Examples include: Allergic reactions like a skin rash or itching, difficulty in breathing, severe swelling of the skin and body, and/or anaphylactic shock (oxygen in your blood do not get enough oxygen), as well as worsening of renal function.
  • Damage or irritation to the throat or tube to the stomach (due to transesophageal echocardiography)
  • Damage or irritation to the windpipe (due to breathing tube)
  • Damage to the blood vessels (e.g., in upper leg) that are cut into for the procedure, or to the area around them
  • Damage to the aorta (main blood vessel carrying blood pumped from the heart to the rest of the body)
  • Other effects or symptoms (e.g., abnormal lab values, fever, high or low blood pressure, dizziness/fainting, nausea/vomiting, swelling or excess fluid build-up, lymphatic complications, urinary tract infection, multi-system organ failure, bleeding in or blocked blood flow to stomach/intestines)
  • Valve implant does not function properly (e.g., leaks, breaks, becomes blocked, wears)

The risks of the investigational Intrepid valve procedure are similar to the surgical risks listed above; however, some may be increased with the Intrepid valve insertion procedure or the valve itself. For example, the risks of cardiac damage may be increased by the delivery of the Intrepid valve, and the risk of valve implant dysfunction (as compared to surgical replacement valves) has not yet been established.

In addition to the risks listed above, the potential risks specifically associated with the delivery of the Intrepid valve may include, but are not limited to, the following:

  • Valve implant is not sized or placed correctly, or moves
  • Impaired heart function due to ventricular incision
  • Damage to the heart
  • Damage to the mitral valve preventing later surgical valve replacement.
  • Blocking blood being pumped out of the heart
  • Emergent surgical or transcatheter intervention (e.g. coronary artery bypass, heart valve replacement or repair, transcatheter valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty, transcatheter valve or component retrieval)
  • Failure to deliver TMVR valve to the intended site
  • Failure to retrieve TMVR System components
  • Piece of the TMVR System breaks off in the body
  • Blood clotting in the TMVR System
  • Extended time on heart-lung bypass, breathing machine, anesthesia, and/or procedure time
  • Radiation skin burn or tissue reaction

If any of the above complications occur, they may be serious and may lead to repeat or prolonged hospitalization, repeat procedures, emergency surgery, other emergency procedures, or in rare cases, death.

The study doctor and/or research staff will make every effort to minimize any risks. For example, as stated above, you will be prepared for connection to the heart-lung machine prior to the Intrepid valve procedure. If there is a problem with the delivery of the Intrepid valve or the valve itself, this allows the study doctor to rapidly start the heart-lung machine and perform open heart surgery to resolve the problem.

Radiation risks

As a result of your participation in this study, you will be exposed to radiation from X-ray procedures. In addition to the routine procedures you will undergo, the X-ray exams used for this study include a chest X-ray, right heart catheterization, coronary arteriography, fluroscopy and chest CT scans. This radiation may slightly increase the risk of cancer.

The study doctor will further explain to you how many X-rays you will have, what X-rays are part of your normal care and what, if any, are extra for this clinical study.

Other possible side-effects and inconveniences

Valve implantation with Fluoroscopy:
After the fluoroscopic procedure, the skin area exposed to the X-rays could feel like it has a sunburn. A skin reaction, if it occurs at all, could show up from a few hours to a few weeks after the procedure, and usually goes away on its own. If you have a skin reaction, you should promptly report this to the study doctor.

ECG:
Possible side effects of the ECG are skin irritation, itching and redness from the ECG electrode pads

Drawing Blood:
Having a blood sample taken may cause some discomfort, bruising, minor infection or bleeding. If this happens, it can be easily treated.

MDCT Scan:
Lying in the Multi-Detector Computed Tomography (MDCT) scan may be uncomfortable, as you will be asked to hold your breath for a short time to allow for better imaging quality. You will also be exposed to noise when you lie within the narrow MDCT device. On average, a MDCT chest scan delivers an average of [add correct number according to local calculation] mSv of radiation.

Female Participants:
The effects of the TMVR procedure on the unborn child and on the newborn baby are not known.

Because of this, it is important that clinical study participants are not pregnant or breast-feeding and do not become pregnant during the course of the clinical study. You will not be able to participate in this clinical study if you are pregnant or trying to become pregnant, or breast-feeding. If you are female and child-bearing is a possibility, you will be required to undergo a pregnancy test prior to commencing the research project. If you do become pregnant while participating in the clinical study, you should inform the study doctor immediately.

There may be additional risks related to this study that are not yet known.