Research

The mission of the Columbia Interventional Cardiovascular Care Clinical Research Group is to provide innovative and compassionate care to our patients through participation in clinical trials, to advance the state of knowledge in the field of interventional cardiology, and to broadly disseminate our findings for the benefit of existing and future patients. 

Our physicians are pioneers in investigating innovative treatment solutions for patients with cardiovascular disease. Many of our clinicians have been, and continue to be, national leading principal investigators for groundbreaking clinical trials examining new and innovative minimally invasive treatments for heart and vascular disease.

Our research has been instrumental in furthering the technologies in virtually every area of interventional cardiac and vascular therapies, including:

• Transcatheter Aortic Valve Replacement (TAVR) - Perhaps the most significant and impactful trials in all of cardiac medicine in the past 20 years, the Columbia-led PARTNER trials helped establish transcatheter valve replacement as a viable alternative to surgery.
• Mitral Valve Repair - The COAPT trial contributed to the approval of the MitraClip Percutaneous Therapy for high-surgical-risk patients, offering a much-needed treatment option for this underserved patient population.
• Tricuspid Valve Replacement - Columbia was a key participant in the TRICEND trials, leading the way for the EVOQUE Replacement System, the first DA-approved transcatheter tricuspid valve replacement device.

What is a Clinical Trial?

A clinical trial is defined as research using human volunteers (also called participants) that is intended to add to medical knowledge. Participants receive a specific intervention — which could be a medical strategy, treatment, or a device — to determine whether it is safe and effective for humans. Clinical trials are the best way to understand the risks and benefits of a treatment.

• Before a treatment is tested on a participant through a clinical trial, it is studied for many years in a laboratory. 
• Once researchers determine that the new method is likely to succeed and is a better medical solution than current treatment options, it has to go through a rigorous review and approval process, which involves presenting a “clinical trial protocol” (or study methodology) to the Food & Drug Administration (FDA). 
• Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, community advocates, and others. 
• The IRB is charged with ensuring that all clinical trials are ethical and that the rights, safety, and well-being of the participants are protected.
• Once a trial is FDA and IRB approved, a small number of patients can be enrolled to determine feasibility.
• If there are signs of benefit from data collected, larger-scale studies with more patients are added. 
• Once enough data is collected, it is presented to the FDA where the information is scrutinized. 
• If the FDA believes, based on the evidence presented, that the therapy is safe and effective, it will be approved for medical consumers.

Benefits of Participating in a Clinical Trial

• Access to innovative treatments and state-of-the-art care before they are widely available
• Playing a more active role in one’s own health care
• Receiving regular and consistent medical care during the course of study participation
• Helping others by contributing to advancements in medical research

How to Enroll in a Clinical Trial

• There are specific criteria, called inclusion criteria, which are used to determine your eligibility to participate in a clinical trial. These may include factors such as age, medical history, or current medical condition. 
• Once it is determined that you are eligible to enroll in a clinical trial, you will spend time with one of our research coordinators to go over important information associated with study participation, including:
  • An explanation for the purpose of the clinical trial
  • The expected duration of participation
  • Study-related procedures and follow-up requirements
  • Risks and benefits of study participation
  • Alternative treatments
• Once you have had the opportunity to review the information and have all of your questions answered, you will be asked to provide informed consent by signing a consent form. 
• Participation in a clinical trial is always voluntary and you are able to withdraw from participating at any time during the course of the study.