
TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
Aortic Valve StenosisBalloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

Inflammatory Response to Aortic Valve Replacement
Aortic Valve StenosisA controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.

The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic...
Aortic Valve StenosisThe primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.

REPRISE Next Generation Delivery System
Aortic StenosisTo confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System...
Aortic Valve StenosisThe purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement.

Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin...
Severe Aortic StenosisTranscatheter Aortic Valve Replacement1 moreThe objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

The SOLACE-AU Clinical Trial
SevereSymptomatic Aortic StenosisThe objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Medtronic CoreValve Evolut R U.S. Clinical Study
Aortic StenosisThe study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.

Progel Vascular Sealant
Aortic Valve StenosisAneurysm of Ascending Aorta2 moreThis study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of...
Severe Aortic StenosisThe 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 very high risk and high risk for aortic valve surgery.