Transcatheter Aortic Valve Replacement with the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement/ Continued Access Trial Save

Date Added
April 26th, 2016
PRO Number
Pro00054065
Researcher
Daniel Steinberg

List of Studies


Profiles_link
Keywords
Heart, Surgery
Summary

The CoreValve System and Evolut R have both been approved by the Food and Drug Administration (FDA) for use in patients who are at high and extreme risk for surgical aortic valve replacement (SAVR). This means that CoreValve and Evolut R are commercially available for use in patients who are deemed high or extreme risk for SAVR by their doctor. However, CoreValve and Evolut R have not been approved by the FDA for use in patients who are at low risk for SAVR. Therefore, the CoreValve System and Evolut R System are considered "investigational devices" in this low risk patient population and research studies are required to determine if they are safe, and provide clinical benefit.

The randomized phase of the trial (above) has concluded, and a new phase has been initiated, which is called single arm (non-randomized). In this phase, all patients will receive a study device. The study doctor will schedule 4 visits with that include a baseline/pre-implant, implant, 1 month, and 12 month visit. Information about the participant will continue to be collected for 10 years after the implant procedure.

The devices being used in this study are considered investigational because they have not been approved by the U.S. Food and Drug Administration (FDA) for patients like you who are at low risk for major complications from open heart surgery to replace the aortic valve. The study devices have, however, been approved by the FDA for use in patients who are at intermediate, high, and extreme risk for SAVR. This means that they are commercially available for use in patients who are deemed intermediate, high or extreme risk for SAVR by their doctor. Although the study devices are considered investigational in the patient population being studied, none of the procedures in this research study are experimental, including the implant itself.

Institution
MUSC
Recruitment Contact
Suzanne Richardson
843-876-0940
RICSU@MUSC.EDU

Impella RP System HDE Save

Date Added
April 21st, 2015
PRO Number
Pro00042253
Researcher
Daniel Steinberg

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This is not a research study. This HDE provides for commercial use of the Impella RP System for acute right ventricular heart failure or decompensation.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation Save

Date Added
December 9th, 2014
PRO Number
Pro00039037
Researcher
Daniel Steinberg

List of Studies


Profiles_link
Keywords
Heart
Summary

To evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure patients who are not candidates for mitral valve surgery.

Institution
MUSC
Recruitment Contact
Suzanne Richardson
843-876-0940
ricsu@musc.edu

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