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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.
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:
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:
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.
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.
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.
Possible side effects of the ECG are skin irritation, itching and redness from the ECG electrode pads
Having a blood sample taken may cause some discomfort, bruising, minor infection or bleeding. If this happens, it can be easily treated.
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.
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.