Phase
Condition
Congestive Heart Failure
Heart Defect
Treatment
Transcatheter Aortic Valve Replacement
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must provide written informed consent prior to any clinicalinvestigation-related procedure.
Are >60 years of age in host country, have severe symptomatic (NYHA class ≥ II)aortic stenosis (AS), at high or extreme surgical risk and have been identified as acandidate for a Portico or Navitor valve implant.
Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documentedheart team agreement of high or extreme risk for surgical aortic valve replacementdue to frailty or co-morbidities not captured by the STS score.
Exclusion
Exclusion Criteria:
Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any timeAND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lungtissue, etc.)
Have sepsis, including active endocarditis
Have any evidence of left ventricular or atrial thrombus
Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severecalcification) that make insertion and endovascular access to the aortic valveimprobable
Have a non-calcified aortic annulus
Have congenital bicuspid or unicuspid leaflet configuration
Are unable to tolerate antiplatelet/anticoagulant therapy
Are pregnant at the time of signing informed consent
Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)
Study Design
Study Description
Connect with a study center
Apollo Hospital
Chennai,
IndiaSite Not Available
Medanta-The Medicity
Gurgaon,
IndiaSite Not Available
Rajasthan Hospital
Jaipur,
IndiaSite Not Available
Seth GS Medical College & KEM Hospital
Mumbai,
IndiaSite Not Available
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi,
IndiaSite Not Available
Christian Medical College & Hospital
Vellore,
IndiaSite Not Available
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