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Clinical Trials

Investigators at the Bluhm Cardiovascular Institute’s Clinical Trials Unit (BCVI-CTU) conduct clinical research trials on all aspects of heart and vascular disease. Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

The following searchable list includes all Department of Medicine clinical trials currently looking for participants. Find information on participating in the research done through the BCVI-CTU via our Frequently Asked Questions page. For more information about our clinical trials, please contact the CTU Regulatory Team.

REPAIR-MR The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve. Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward. The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm. Eligibility Criteria Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL. Subject is at least 75 years of age Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04198870IRB number STU00211557 More Info Keywords Heart Failure Heart Surgery Severe MR MitraClip MitralValve Repair Email Patalino, Jessica Phone

REPAIR-MR

The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

Eligibility Criteria

Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
Subject is at least 75 years of age

Principal Investigator

Davidson, Charles J

Location(s)

Map it 201 E. Huron St.
Chicago, IL

ClinicalTrials.gov IdentifierNCT04198870IRB number STU00211557

More Info

Keywords Heart Failure Heart Surgery Severe MR MitraClip MitralValve Repair

Email Patalino, Jessica Phone