China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population...
Aortic StenosisSymptomatic Aortic Stenosis1 moreTo evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic...
Aortic Valve DiseaseA prospective, multicenter, nonrandomized, single-arm, clinical study.
Freedom SOLO Stentless Heart Valve Study
Aortic StenosisAortic InsufficiencyThe purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With...
Aortic RegurgitationTo investigate the performance of currently available THVs in terms of safety and efficacy To evaluate potential predictors of THV embolization or migration (TVEM) To assess the impact of TVEM on prognosis
Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot...
Coronary Artery DiseaseMitral Valve Insufficiency4 moreAmbulation following surgery has been found to be beneficial for patients; however, nurses and doctors struggle with getting post-operative, hospitalized patients to walk on their own. One promising strategy to address this might be an ambulation orderly, an employee whose single responsibility is to assure that patients walk 3-4 times per day. However, the effect of the ambulation orderly on post-operative physical activity has not yet been described. It is important to quantify what the ambulation orderly does in order to assess if this is an effective method for helping patients walk. As a result, the investigators will perform a pilot randomized controlled trial to test the effects of an ambulation orderly in patients hospitalized with recent cardiac surgery. Half of the patients will be assigned to walk with the ambulation orderly 3-4 times/day and the control group will be given standard nursing encouragement and assistance and encouragement to walk. The investigators will evaluate the average total daily step counts (over the hospital course, usually 4-7 days) and the change in walking distance between a baseline and a final 6 minute walk test. The investigators will also evaluate exercise physiologic parameters (heart rate, oxygen saturation) during ambulation, patient functional independence, and patient satisfaction.
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
Aortic InsufficiencyThis investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Coronary Artery DiseaseAortic Valve Disorder3 moreThe purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Aortic Valve Replacement With Trifecta(TM)
Aortic Valve InsufficiencyRegurgitation3 moreThe purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Aortic Valve InsufficiencyAortic Valve Regurgitation6 moreThe purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
An Observational, Prospective Evaluation of the Trifecta™ Valve
Aortic Valve InsufficiencyRegurgitation3 moreThis trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.