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Valve

http://www.columbiaheartvalve.org/

Mitral Valve

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

Short Description: The objective of this study is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe 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. Patient eligibility is assessed based on TTE, TEE, diagnostic catheterization, and surgical consultation. The study is randomized on a 1:1 basis, with assignment to either a "control group" that will NOT receive the study device but rather continue with medical therapy only or a "treatment group" that will receive the device (and also continue with medical therapy). Up to 350 patients will participate 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.

Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Susheel Kodali, MD

https://clinicaltrials.gov/ct2/show/NCT01626079?term=COAPT&rank=1

Sponsor: Abbott Vascular, Inc.

 

GDS: Early Feasibility of the AccuCinch® Ventriculoplasty System

Short Description: Mitral regurgitation is a valvular disease in which the mitral leaflets do not seal properly. As a result, blood leaks backwards in the heart forcing a constant strain on the cardiac muscle. Over time, this disorder can result in many complications including atrial fibrillation (abnormal heart rhythm), an enlarged heart and congestive heart failure.
There are general options to treat patients with Mitral regurgitation for example:
· Medications;
· For certain cases, implantation of an electrical device to control the way your heart beats;
· Open heart surgery to replace or repair the valve that is allowing backflow between chambers.
The most widely recognized treatment is with medications, only. However, this does not cure the disease, it only slows the process. The Accucinch device has been FDA approved for use in just a small number of patients because it is a very innovative approach for treating heart failure. The Accucinch is inserted into the heart through a series of flexible tube-like devices called “catheters” that are placed through a blood vessel in your groin and does not require open heart surgery to be implanted. The largest of these tubes is slightly smaller in diameter than a pencil. This new approach imitates a surgical procedure, but does not require your doctor to perform open heart surgery. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Susheel Kodali, MD

https://clinicaltrials.gov/ct2/show/NCT02624960?term=GDS&rank=10

Sponsor: Ancora Heart

 

Trans in MAC: Mitral Implantation of TRAnscatheter vaLves

Short Description: Mitral stenosis (MS) is a narrowing of the mitral valve in the heart restricting the flow of blood. The cause of mitral stenosis is heart disease in most cases. Surgical correction of the mitral valve in MS results in significant improvement of symptoms and survival. This study will fix the diseased mitral valve using catheter based intervention. Study patients will undergo clinical follow-up at discharge, 30 days, 6 months, and 1 year, and then annually thereafter for a minimum of 5 years post index procedure. There will be a phone follow-up at the analysis close date.

Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Martin B. Leon, MD

https://clinicaltrials.gov/ct2/show/NCT02370511?term=mitral&rank=2

Investigator Initiated

 

Twelve: Evaluation of the Safety and Performance of The Twelve Intrepid™ Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation -The Twelve Intrepid TMVR Pilot Study

Short Description: Mitral valve regurgitation is the most common type of heart valve defect that typically affects patients 75 and older. Mitral regurgitation develops when the mitral valve cannot close entirely causing blood to drawback into the mitral valve during left ventricle contraction. Ultimately, if not treated the risk of heart failure, stroke, valve inflammation, and death heightens. Mitral valve replacement by the use of the Twelve TMVR System is an alternative option for patients who are not candidates for conventional mitral repair. The Twelve TMVR system offers a less invasive approach when repairing the mitral valve but as with any other cardiac surgery there are associated risk with this procedure. These risk include but are not limited to cardiac damage, heart rhythm disturbance, reduced cardiac functions, pulmonary complications, and death.
Mitral surgical repair is performed through trans-spacial access (a small incision in the chest cavity, allowing the insertion of the guide system by the use of a catheter (a small tube) to delivery and implant the device in the left ventricle. Following the procedure patients will be prescribed specific anticoagulation and antiplatelet therapy for 3-6 months at the discretion of the physician. Patients will be expected to return for follow-up visits at 1, 3, 6 and 12 months, and every 6 months through 5 years to monitor their disease improvement.

Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Martin B. Leon, MD

https://clinicaltrials.gov/ct2/show/NCT02428010?term=twelve&rank=1

Sponsor: Medtronic

 

Tricuspid Valve

Forma: Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Short Description:Tricuspid Regurgitation (TR) is a disorder in which the Tricuspid valve, the valve in between the two right chambers that does not close properly. As a result, blood flows backward through the Tricuspid valve. The purpose of the study is to evaluate the safety and effectiveness of the Edwards 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 5 centers within the United States.. All enrolled participants will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.

Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Susheel Kodali, MD

https://clinicaltrials.gov/ct2/show/NCT02471807?term=forma&rank=1

Sponsor: Edwards

 

Scout: Early feasibility of the mitralign percutaneous tricuspid valve annuloplasty system (ptvas) for symptomatic chronic functional tricuspid regurgitation.

Short Description: This is a prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study device uses a catheter-based approach to suture the tricuspid valve thus decreasing the size of valve and therefore decrease leaking. 30 subjects with chronic functional tricuspid regurgitation from up to six sites in the U.S. will be treated with the PTVAS
All subjects receiving an implant will be followed for 2 years. Follow-up will comprise of a subject visit to the out-patient clinic and a transthoracic echocardiography to assess tricuspid function and the cardiac hemodynamic status at all follow-up visits. Also, laboratory, quality of life questionnaires and a 6-minute walking distance test will be performed. At the 6-month follow-up visit, the trans-esophageal echocardiography and a right heart catheterization will be repeated. Subjects will be administered aspirin for a minimum of 6 months after the procedure.

Patients will follow up at 1, 3, 6, 12 and 24 months. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Rebecca hahn, MD

https://clinicaltrials.gov/ct2/show/NCT02574650?term=scout&rank=18

Sponsor: Mitralign

 

Aortic Valve

Partner 3: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis
Requiring Aortic Valve Replacement

Short Description:This is a multicenter, randomized study enrolling patients with severe, calcific, aortic stenosis requiring aortic valve replacement who are at low operative risk. Patients will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. A subset of eligible patients from each study arm will be enrolled in a computed tomography (CT) sub-study at select sites. Approximately 1228 patients will be enrolled at up to 65 sites. Patients will be followed at intervals for 10 years. Follow-up visits will occur at 30 Days, 6 Months, 1 year and annually through 10 years, and will include transthoracic echocardiogram, lab tests, neuro assessment, 6 minute walk test and quality of life questionnaires. Please contact Marian Hawkey RN at mh2403@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Susheel Kodali, MD

https://clinicaltrials.gov/ct2/show/NCT02675114?term=partner+3&rank=2

Sponsor: Edwards Lifescience

 

TAVR Unload: SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis

Short Description: This is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of TAVR with the SAPIEN 3 transcatheter heart valve and optimal heart failure therapy (OHFT) versus OHFT alone in HF patients with moderate aortic stenosis. Approximately 600 patients will be enrolled at up to 40 sites. All patients will be followed for 2 years. Follow-up visits will occur at 30 Days, 6 Months, 1 year and 2 years, and will include transthoracic echocardiogram, lab tests, neuro assessment, 6 minute walk test and quality of life questionnaires. Please contact Marian Hawkey RN at mh2403@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Susheel Kodali, MD

https://clinicaltrials.gov/ct2/show/NCT02661451?term=tavr+unload&rank=1

Sponsor: Cardiovascular Research Foundation

 

 

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