Past Clinical Trials

The Center for Interventional Vascular Therapy (CIVT) has been involved in many groundbreaking clinical trials examining new and innovative minimally invasive treatments for heart and vascular disease.

PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial (PARTNER)

CIVT served as the national principal investigation site for the PARTNER Trial, the clinical study which led to the FDA’s approval of the transcatheter aortic valve replacement (TAVR) in the U.S. in November of 2011.

PARTNER II Trial: Placement of AoRTic TraNscathetER Valve Trial (PARTNER II)

We were also investigators for the PARTNER II Trial which is evaluating the TAVR for an expanded patient population.

COAPT Trial: Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients

The objective of the COAPT Trial is to confirm the safety and effectiveness of the MitraClip system for the treatment of functional mitral regurgitation (FMR) in high surgical risk subjects. FMR occurs when the two leaflets of the heart's mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. Up to 350 patients participated in this study across North America and will follow-up for 5 years. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System in high surgical risk patients.

Principal Investigator: Susheel Kodali, MD
Sponsor: Abbott Vascular, Inc

*Columbia University receives royalties from Abbott Vascular for sale of the MitraClip*

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Tricuspid regurgitation (TR) is a disorder in which the tricuspid valve, the valve in between the two right chambers of the heart, does not close properly. As a result, blood flows backward through the tricuspid valve. The purpose of the FORMA study is to evaluate the safety and effectiveness of the Edwards FORMA tricuspid transcatheter repair system in treating TR. The tricuspid valve repair implant consists of a foam encased in a balloon that is intended to fill the space in the diseased tricuspid heart valve and provide a surface for native valve leaflets to minimize the incorrect flow of blood in your heart. Up to 30 patients will be enrolled in the study at five centers within the United States.. All enrolled participants will be assessed for clinical follow-up at one month, six months, one year and annually for three years post implant procedure.

Principal Investigator: Susheel Kodali, MD
Sponsor: Edwards Lifesciences