Pre-Op Instructions

The Integra-D Clinical Trial is a clinical research study that investigates the safety and effectiveness of a new type of implantable defibrillator (ICD) called the Integra-D. The Integra-D is a smaller and more efficient ICD than traditional ICDs, and it is designed to improve the quality of life for people with heart failure.

What is the Integra-D Implantable Defibrillator?

The Integra-D implantable defibrillator (ICD) is a revolutionary new device that represents a major advancement in the treatment of heart failure. The Integra-D is smaller, more efficient, and more patient-friendly than traditional ICDs, making it a more comfortable and effective option for patients.

The Integra-D's smaller size and streamlined design allow for a minimally invasive implantation procedure, which means less pain and a faster recovery time for patients. The Integra-D is also more efficient, using less energy to deliver shocks to the heart. This means that the Integra-D can last longer on a single battery charge, reducing the need for battery replacements.

In addition to its physical advantages, the Integra-D also offers a number of patient-centric features that make it a more comfortable and convenient option for patients. For example, the Integra-D can be programmed to deliver shocks at a lower energy level, which can reduce the risk of pain and discomfort for patients. The Integra-D also features a remote monitoring system that allows patients to check their device status from home, eliminating the need for frequent clinic visits.

The Integra-D implantable defibrillator is a significant advancement in the treatment of heart failure. With its smaller size, greater efficiency, and patient-friendly features, the Integra-D offers a new standard of care for patients with this condition.

Who is a Candidate for the Integra-D Clinical Trial?

The Integra-D Clinical Trial is a research study that is looking for people with heart failure who are at high risk for sudden cardiac death. To be eligible for the study, you must meet the following criteria:

  • Have heart failure with reduced ejection fraction (HFrEF)
    This means that your heart is not pumping blood as well as it should.
  • Be at high risk for sudden cardiac death
    This means that you have a greater chance of dying suddenly from a heart rhythm problem.
  • Be at least 18 years old
    This is because the study participants need to be able to understand the risks and benefits of the study and give their consent to participate.
  • Have a projected life expectancy of at least 1 year
    This is to ensure that the study participants are likely to benefit from the study and that their safety can be monitored throughout the study period.
  • Be able to understand and consent to the study
    This means that you need to be able to understand the risks and benefits of the study and give your consent to participate.
  • Be willing and able to comply with the study protocol
    This means that you need to be willing to follow the study's rules and procedures, such as attending regular study visits.
  • Not have any major medical conditions that could interfere with the study
    This is to ensure that the study participants are safe and that the results of the study are not biased by other medical conditions.

Integra-D
Implantation Procedure

The Integra-D implantation procedure is a minimally invasive surgery that is performed under general anesthesia. The procedure typically takes about 1-2 hours to complete.

The first step in the procedure is to make a small incision in the chest. The Integra-D device is then inserted into the chest through the incision. The device is attached to the heart muscle with leads. The incision is then closed with stitches or staples. The device is programmed to monitor the heart rhythm and deliver a shock if it detects a dangerous heart rhythm. The device also has a remote monitoring feature that allows the doctor to check the device status from a remote location.

The Integra-D implantation procedure is typically well-tolerated by patients. Most patients are able to go home the same day as the procedure. There is a small risk of complications, such as infection, bleeding, or discomfort at the implant site. Here are some of the steps involved in the Integra-D implantation procedure:

  • The patient is taken to the operating room and placed under general anesthesia.
  • A small incision is made in the chest.
  • The Integra-D device is inserted into the chest through the incision.
  • The device is attached to the heart muscle with leads.
  • The incision is closed with stitches or staples.
  • The patient is taken to the recovery room to wake up from anesthesia.
  • The patient is discharged from the hospital the same day or the next day.

Interested in Taking Part in the Integra-D Clinical Trial?

If you are a patient with heart failure who is at high risk for sudden cardiac death, you may be eligible to participate in the Integra-D Clinical Trial. The trial is currently enrolling patients at participating sites across the United States. Request an appointment with our cardiologists to find out if you are eligible to participate in the Integra-D Clinical Trial.

The Integra-D Clinical Trial is a vital research study that has the potential to improve the lives of patients with heart failure. If you are eligible to participate, please consider doing so. Your participation could help to make a difference in the fight against heart disease.

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