Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement
Recruiting in Palo Alto (17 mi)
+42 other locations
DH
Overseen byDavid H Adams
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Medtronic Cardiovascular
No Placebo Group
Trial Summary
What is the purpose of this trial?
To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.
Research Team
DH
David H Adams
Principal Investigator
Mount Sinai Health System
Eligibility Criteria
Inclusion Criteria
Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
See 7 more
Treatment Details
Interventions
- Medtronic CoreValve® System (Transcatheter Aortic Valve Implantation)
Participant Groups
6Treatment groups
Experimental Treatment
Group I: Severe (≥3-4+) Tricuspid Valve RegurgitationExperimental Treatment1 Intervention
Tricuspid valve regurgitation ≥3-4+
Group II: Severe (≥3-4+) Mitral Valve RegurgitationExperimental Treatment1 Intervention
Mitral valve regurgitation ≥3-4+
Group III: Low Gradient Low Output Aortic StenosisExperimental Treatment1 Intervention
Low gradient low output aortic stenosis
Group IV: Failed Bioprosthetic Surgical Aortic ValveExperimental Treatment1 Intervention
Stenosed, insufficient or combined bioprosthetic surgical aortic valve failure
Group V: End Stage Renal Disease (ESRD)Experimental Treatment1 Intervention
End stage renal disease requiring renal replacement therapy or a creatinine clearance (CRCL) \<20 cc/min, but not on dialysis
Group VI: 2 or More ConditionsExperimental Treatment1 Intervention
2 or more of the listed conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiovascular
Lead Sponsor
Trials
78
Recruited
37,300+
Geoff Martha
Medtronic Cardiovascular
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Kendra J. Grubb
Medtronic Cardiovascular
Chief Medical Officer
MD from Emory University