Use of the Self-Expanding Medtronic CoreValve Prosthesis Without Predilation in Patients With Severely IMPaired Left-VentrIcular Ejection Fraction for TAVI Trial - The SIMPLIFy TAVI Trial
Status: Completed
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• LVEF ≤35%
• Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2)
• Males or females at least 18 years of age
• Logistic EuroSCORE ≥15% and age ≥75 years or if age \<75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)
• Signed informed consent
Locations
Other Locations
Germany
Department of Medicine II - Cardiology, University Hospital Bonn
Bonn
Department of Cardiology, University Hospital Düsseldorf
Düsseldorf
West German Heart Center, University Hospital Essen
Essen
Department of Medicine III - Cardiology, University Hospital Heidelberg
Heidelberg
Department of Cardiology, Hospital Barmherzige Brüder Trier
Trier
Department of Medicine III - Cardiology, University Hospital Tübingen
Tübingen
Time Frame
Start Date: 2013-01-09
Completion Date: 2019-11-22
Participants
Target number of participants: 110
Treatments
Experimental: TAVI without predilation
Active_comparator: Standard TAVI procedure
Authors
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bonn