Corevalve pivotal study clinical

Transcatheter Aortic-Valve Replacement with a Self ...

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Study Design. This study was a multicenter, randomized, noninferiority trial performed at 45 clinical sites in the United States (Table S1 in the Supplementary Appendix, available with the full ...

Transcatheter Aortic-Valve Replacement with a Self ...

CoreValve® U.S. Pivotal Trial | Johns Hopkins Heart and ...

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Medtronic CoreValve® U.S. Pivotal Trial (High Risk Inoperable Patients) and (High Risk Surgical Patients) ... Study Long Title: Medtronic CoreValve® U.S. Pivotal Trial | High Risk Patients ... update or delete a clinical trial for the Heart and Vascular Institute website? Use this form.

CoreValve® U.S. Pivotal Trial | Johns Hopkins Heart and ...

TAVR Heart Valve Replacement - Clinical Study Results ...

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The study results at 1 year showed: The CoreValve procedure had an acceptable safety profile and was an effective alternative to surgery. More CoreValve heart valve patients were alive than surgical patients. Extreme Risk Study Overview. These patients were too sick for surgery.

TAVR Heart Valve Replacement - Clinical Study Results ...

Safety and Efficacy Study of the Medtronic CoreValve ...

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11/15/2010 · The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

Safety and Efficacy Study of the Medtronic CoreValve ...

CoreValve US Pivotal Trial ACC 2015 - Clinical Trial Results

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CoreValve US Pivotal Trial . ACC 2015 . ... display of the data presented. I serve on a Medical Advisory Board for Medtronic, Inc. ACC 2015 • The randomized CoreValve trial demonstrated that transcatheter aortic valve replacement (TAVR) resulted ... Clinical and Anatomic Exclusion Criteria Were: • Recent active GI bleed (<3 months), stroke ...

CoreValve US Pivotal Trial ACC 2015 - Clinical Trial Results

Medtronic CoreValve Evolut R U.S. Clinical Study - Full ...

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8/4/2014 · Medtronic CoreValve Evolut R U.S. Clinical Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.

Medtronic CoreValve Evolut R U.S. Clinical Study - Full ...

The CoreValve US Pivotal Trial

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Study Purpose: To evaluate the safety and efficacy of the CoreValve THV for the treatment of patients with symptomatic severe aortic stenosis in whom the predicted risk of operative mortality or serious, irreversible morbidity was 50% or greater at 30 days Risk Determined by: Two Clinical Site Cardiac Surgeons and One Interventional Cardiologist

The CoreValve US Pivotal Trial

The CoreValve US pivotal trial | Request PDF

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The CoreValve US pivotal trial. ... 12,13 The CoreValve US PIVOTAL study was ini- tially developed to assess for non-inferiority of TAVI compared with SAVR; however, the apparent benefit of TAVI ...

The CoreValve US pivotal trial | Request PDF

CoreValve US Pivotal Trial: TAVR with a Self-Expanding ...

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3/28/2014 · Transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis had a significantly higher rate of survival at one year than surgical aortic valve replacement in patients with severe aortic stenosis, according to results of the CoreValve US Pivotal Trial presented March 29 as part of ACC.14 in Washington, DC, and simultaneously published in the New England Journal of Medicine.

CoreValve US Pivotal Trial: TAVR with a Self-Expanding ...

COVER STORY CoreValve: Assessing the Clinical Trials

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he CoreValve clinical trials that have recently been published include the US Pivotal Extreme Risk study, the randomized US High Risk study, and the ADVANCE study.1-3 In this article, we review the device, clinical trial patient selection and results, and clinical implications of these trials. KEY …

COVER STORY CoreValve: Assessing the Clinical Trials

Corevalve US Pivotal Trial CoreValve US Pivotal Clinical ...

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Corevalve US Pivotal Trial CoreValve US Pivotal Trial Extreme Risk High Risk 2 Adams DH, Popma JJ, Reardon MJ, et al. New Engl J Med 2014; 18Fr delivery system 4 valve sizes (18-29 mm annular range) Transfemoral Subclavian Direct Aortic Study Device and Access Routes Trial …

Corevalve US Pivotal Trial CoreValve US Pivotal Clinical ...

Transcatheter Aortic Valve Replacement - Clinical Evidence ...

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The High Risk CoreValve Pivotal Trial is a prospective, randomized, multicenter, noninferiority trial to compare the safety and efficacy of the Medtronic CoreValve system to SAVR in patients with symptomatic severe aortic stenosis at increased surgical risk. ... The Evolut R US Clinical Study is a prospective, multicenter, controlled ...

Transcatheter Aortic Valve Replacement - Clinical Evidence ...

The CoreValve US Pivotal Trial - ScienceDirect

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The CoreValve US Pivotal Trial Design. ... The CoreValve platform continues to evolve, and the next-generation or Evolut R valve has begun clinical evaluation in the United States. This valve allows resheathing, repositioning, and redeployment to ensure accurate placement. ... The CoreValve US Pivotal Study was funded by Medtronic, Inc ...

The CoreValve US Pivotal Trial - ScienceDirect

The CoreValve US Pivotal Trial - Seminars in Thoracic and ...

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10/24/2014 · The CoreValve US trial enrolled patients with symptomatic severe aortic stenosis into 2 separate cohorts: an extreme-risk cohort and a high-risk cohort. The study of transfemoral TAVR using the CoreValve system in extreme-risk patients achieved its primary end point of …

The CoreValve US Pivotal Trial - Seminars in Thoracic and ...

Medtronic Corevalve U.S. Pivotal Trial Results Reveal Positive

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News Release. Medtronic Media Contacts: ... MDT) today announced the highly anticipated results from the CoreValve U.S. Pivotal Trial, the first U.S. data presented on the Medtronic CoreValve® System. The study of the novel self-expanding device, presented at a late-breaking clinical trial session of the Transcatheter Cardiovascular ...

Medtronic Corevalve U.S. Pivotal Trial Results Reveal Positive

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

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PAS 1 Continued follow-up of the IDE pivotal cohort (extreme risk patients): This study should be conducted per protocol in PAS 1 Addendum (Version 1) to Medtronic CoreValve U.S. Pivotal Trial (Extreme Risk Patients) Clinical Investigational Plan (Version 12) as submitted to FDA by email on December 13, 2013. The study will consist

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

CoreValve® U.S. Pivotal Trial - Continued Access Protocol ...

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Medtronic CoreValve® U.S. Pivotal Trial Continued Access Protocol. Find a Doctor. Find a doctor at The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center or …

CoreValve® U.S. Pivotal Trial - Continued Access Protocol ...

Medtronic CoreValve® System Obtains Early FDA Approval on ...

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The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival and some of the lowest rates of stroke and valve ...

Medtronic CoreValve® System Obtains Early FDA Approval on ...

TAVR Outperforms Surgical Valve Replacement in CoreValve ...

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TAVR Outperforms Surgical Valve Replacement in CoreValve Pivotal Trial. ... Final follow-up results from the CoreValve CE pivotal study were also presented at ACC.14, which demonstrated excellent long-term durability at four years in patients with severe aortic stenosis. ... Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical ...

TAVR Outperforms Surgical Valve Replacement in CoreValve ...

CoreValve: Assessing the Clinical Trials - citoday.com

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The CoreValve clinical trials that have recently been published include the US Pivotal Extreme Risk study, the randomized US High Risk study, and the ADVANCE study. 1-3 In this article, we review the device, clinical trial patient selection and results, and clinical implications of these trials. KEY FEATURES OF THE DEVICE

CoreValve: Assessing the Clinical Trials - citoday.com

CoreValve - Food and Drug Administration

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With CoreValve TAVr, a small incision is made and a thin, flexible tube (catheter) holding the CoreValve aortic heart valve is guided to the heart. special imaging equipment is used to guide positioning and placement of the CoreValve aortic heart valve. After the Procedure following CoreValve TAVr, …

CoreValve - Food and Drug Administration
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