ASAP-TOO Clinical Trial

Clinical trials are research studies that look for better ways to prevent, screen for, diagnose, and treat diseases. They can test new medical treatments on people or explore whether already-approved treatments may work for additional conditions or groups of people.

Once physicians and doctors believe a treatment may be effective, they get approval from the Food and Drug Administration and an institutional review board (IRB) to test it with people. An IRB is a committee designated by the institution or hospital to review and approve research studies. The primary purpose of their review is to ensure the protection of the rights and welfare of the people participating in the research.

Why Do Physicians Conduct Clinical Trials?

Clinical trials can explore:

Whether a particular treatment is effective
If there are groups of people who could benefit most from the treatment
If a treatment is safe and whether it has any side effects

Do Clinical Trials Follow Any Guidelines?

Trials follow strict guidelines to ensure participants’ safety and well-being as well as to ensure accurate collection of data. They include two key oversight processes:

Institutional review board (IRB) – All clinical trials are overseen by an IRB, which ensures the study is ethical and that participants’ rights and welfare are protected at all times. This includes ensuring risks are minimized throughout the study and that they are reasonable in relation to any potential benefits. An IRB is made up of doctors, researchers, and members of the community. Some clinical studies are also monitored by data-monitoring committees.
Informed consent – Before you can enroll in a clinical study, you must receive an informed consent document. This process is designed to ensure you understand the trial and everything that participation would involve including the risks, potential benefits, and alternatives to the study. The clinical trial team may also explain things to you in person or via phone and conduct activities or ask questions to ensure you understand completely. If you agree to participate, you will sign and date the informed consent document. Keep in mind this is not a contract; you can withdraw at any time during the study if you choose.

What Is Randomization?

It means some participants will receive the device, and others will stay on their existing treatment. It’s done so scientists can compare the effects of the device versus not using the device. It’s like a coin toss, so everyone has a fair chance of getting the implanted device. Both options include ongoing, high-quality support from cardiologists to help you manage your atrial fibrillation.

Why Are Clinical Trials Important?

They can help physicians find new medical treatments and make improvements to the ones that already exist. Every medical device or drug has been through a clinical trial. If you’re currently using one, that means other people participated in a clinical trial and paved the way for you.

What Is Informed Consent?

Participation in clinical trials is completely voluntary. Before you enroll, it’s important that you understand all the details of study participation including the associated risks. As you’re considering a clinical trial, a study nurse or study physician will provide you with an informed consent form, which describes this information. Take your time to read the form and be sure you understand it. Your doctor or healthcare provider will discuss study participation and guide you through the informed consent process. Please ask your doctor or healthcare provider to answer your questions or explain anything that is not clear to you. Only sign the document if you agree to the commitment and understand everything it says.

Can I Quit a Trial Once I’ve Started It?

As a participant, you have the right to drop out of a clinical trial at any time.

PATIENT SAFETY INFORMATION

The WATCHMAN Device is a permanent implant designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the WATCHMAN™ Closure Device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. In rare cases death can occur. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the WATCHMAN Device.

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