Clinical Trials

As part of an academic medical center, the Department of Surgery at Northwestern University Feinberg School of Medicine aims to improve the human health through scientific research.

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 Surgery clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

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Trials
Partner 3 AVIV Registry This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace … This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally. Principal Investigator Malaisrie, S. Chris Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03003299IRB number STU00204739 More Info Keywords Aortic Valve Transcatheter Aortic Valve Replacement (TAVR) Copy Study URL to Clipboard Copy
APOLLO This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (… This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC). The new investigational device is a mitral valve replacement called the Medtronic IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The IntrepidTM TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 in-person scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure. Eligibility CriteriaEnrolling participants with mitral valve regurgitation who are at high risk of experiencing major complications while undergoing open-heart surgery due to their current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within the body). Additionally, physicians have determined that these participants may not be optimally treated with currently approved transcatheter repair therapies. Principal Investigator Malaisrie, S. Chris Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03242642IRB number STU00206197 More Info Keywords Mitral Valve Regurgitation (MVR) Transcatheter Mitral Valve Repair (TMVR) Email Cortez, Justin Phone Copy Study URL to Clipboard Copy
CLASP IID/IIF The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for … The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team. Eligibility Criteria Primary Inclusion Criteria: Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab Left ventricular ejection fraction (LVEF) ≥ 20% Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03706833IRB number STU00208635 More Info Keywords Mitral Valve Regurgitation MVR Transcatheter Mitral Valve Repair TMVR MitraClip Email Patalino, Jessica Phone Copy Study URL to Clipboard Copy
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 … 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 Copy Study URL to Clipboard Copy
TRISCEND II This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if … This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation. Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04482062IRB number STU00213338 More Info Keywords Tricuspid Valve Transcatheter Email Cortez, Justin Phone 312 694 0298 Copy Study URL to Clipboard Copy
Precision MRI of Left Atrial Fibrosis for Patients with Atrial Fibrillation To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure… To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure Eligibility Criteria Primary Inclusion Criteria: Patients ≥ 18 years old Patients with paroxysmal or persistent AF undergoing routine pulmonary vein isolation (PVI) Patients undergoing a cardiac MRI prior to AF ablation Primary Exclusion Criteria: Contraindication to MRI Abnormal renal function (eGFR < 60 mL/min/1.73 m2) Principal Investigator Kim, Daniel Location(s) Map it 710 N. Fairbanks Ct. Olson Pavilion Chicago, IL Map it 710 N. Fairbanks Court Chicago, IL IRB number STU00213834 More Info Keywords Atrial Fibrillation (Afib) Pulmonary Vein Isolation (PVI) MRI Catheter Ablation Email McKenzie, Alexis Phone Copy Study URL to Clipboard Copy
RESPONDER-HF Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure Eligibility Criteria Chronic symptomatic heart failure (HF) Ongoing stable GDMT HF management and management of comorbidities according to the 2022 ACC/AHA Guidelines for the Management of Heart Failure. Principal Investigator Flaherty, James D Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05425459IRB number STU00217812 More Info Email Roshevsky, Daniel Scott Phone +1 312 695 3264 Copy Study URL to Clipboard Copy
EXTEND Thoraflex Hybrid and Relay Extension Post-Approval Study Eligibility Criteria Patient will undergo treatment with a Thoraflex Hybrid device Principal Investigator Malaisrie, S. Chris Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05639400IRB number STU00219308 More Info Keywords Thoraflex Relay Extension Email Silverman, Andrea Raye Phone Copy Study URL to Clipboard Copy
ARISE-II Evaluation of the GORE® Ascending Stent Graft (ASG device) in the Treatment of Lesions of the Ascending Aorta Eligibility Criteria Ascending Aortic pathologies warranting surgical repair Anatomic compatibility with the ASG device based on Gore Imaging Sciences review Must be considered high-risk for open surgical repair Principal Investigator Mehta, Christopher Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05800743IRB number STU00219695 More Info Keywords GORE Ascending Stent Graft ASG Email Silverman, Andrea Raye Phone Copy Study URL to Clipboard Copy
Preserve Heart Study Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors Eligibility Criteria Listed for heart transplantation Principal Investigator Bryner, Ben Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05881278IRB number STU00220133 More Info Keywords Transplant Xvivo Email Mossell, Allison Josephine Phone Copy Study URL to Clipboard Copy
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’… Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’s own immune system to prevent polyps and cancers is a new approach that we plan to test in patients with LS. We are asking you to take part in this research study because you have been diagnosed with Lynch syndrome and your doctor has previously found polyps or cancer in your colon or rectum. This study is being done to find out if we can lower your chance of getting colon cancer and other Lynch cancers by giving you three vaccines, an approach called Tri-Ad5, in combination with an injectable immune-enhancer protein called N-803. The usual approach for patients with Lynch syndrome is to be followed closely by their doctor with regular colonoscopies, pelvic imaging (ultrasounds), urine tests, computerized tomography scans (CT scans), and skin examinations to watch for the development of cancer. Removal of the colon or uterus before cancer develops is also part of the usual approach. We are doing this study because we want to find out if the vaccines we are testing will be effective at preventing colon polyps and cancers of the colon and other organs. The purpose of this study is to compare the safety and effects of the Tri-Ad5 vaccines alone, or in combination with N-803, versus placebo on the risk of developing colon and other cancers in patients with Lynch syndrome. The Tri-Ad5 vaccines and N-803 are not FDA-approved. This study is looking for volunteers who have been diagnosed with Lynch syndrome. We will enroll 158 participants at institutions across the country. Eligibility Criteria You may be eligible if: You have been diagnosed with Lynch syndrome and have had abnormal growths in your colon or rectum You have not had any cancer treatment in the past 6 months · You are 18 years or older · You are not pregnant or planning to get pregnant Principal Investigator Muller, Charles M ClinicalTrials.gov IdentifierNCT05419011IRB number STU00217456 More Info Keywords lynch syndrome vaccine cancer prevention colon cancer Tri-Ad5 immunoprevention LS Copy Study URL to Clipboard Copy
A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS … Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes. Principal Investigator Borja-Cacho, Daniel ClinicalTrials.gov IdentifierNCT01897688IRB number STU00059469 More Info Keywords Diabetes Islet Pancreas Hypoglycemia T1D Transplant Copy Study URL to Clipboard Copy
TAMBE Pivotal AAA 17-01 This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research … This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research study will look at treating thoracoabdominal or pararenal aneurysm disease with a new device design known as the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (the ‘Study Device’).The Study Device that will be used to treat the aneurysm is called a “stent-graft”. The Study Device combines a surgical graft material with an outer metal mesh-like form (stent). The nonmetal graft component of the Study Device is made of a soft, polymer material (ePTFE). This material is routinely and safely used for surgical procedures throughout the world today. The graft is surrounded on the outside with a metal frame made from an elastic metal (nitinol wire or stainless steel) bent into a wave pattern and shaped to fit the graft. The materials used in the Study Device are not investigational and have a long, safe history of performance in similar applications. Principal Investigator Hoel, Andrew Warfield Location(s) Map it 201 E. Huron St. Suite 12 160 Chicago, IL ClinicalTrials.gov IdentifierNCT03728985IRB number STU00211408 More Info Keywords Abdominal Aortic Aneurysm Aneurysm Email Stat, Madison Rose Phone +1 312 926 3926 Copy Study URL to Clipboard Copy