Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation Transcatheter Aortic Valve Replacement for Pure Severe Aortic Regurgitation Pilot Study

Seung-Jung Park1 site in 1 country2 target enrollmentAugust 10, 2018

ConditionsAortic Valve Aortic Valve Insufficiency Aortic Regurgitation Regurgitation, Aortic Valve Aortic Incompetence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve
Sponsor: Seung-Jung Park
Enrollment: 2
Locations: 1
Primary Endpoint: Aortic regurgitation
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN).

Registry

clinicaltrials.gov

Start Date

August 10, 2018

End Date

February 21, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is ≥15% (STS score ≥10 OR Logistic EuroSCORE ≥20%).
•A candidate who does not meet \[the STS score criteria ≥ 10 OR Logistic EuroSCORE ≥20%\] can be included in the study if a peer review by at least two investigators concluded and documented that the patient's predicted risk of operative mortality is ≥15% from old age, severe frailty or STS score ≥
•In this case, all evidence must be documented in the study case report form as well as in the patient medical record.
•There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline.
•The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
•The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
•The subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography.
•The subject agrees that the subject will cooperate with study team for all required post-procedure visits.
•The subject's age is 20 or more.

Exclusion Criteria

•Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition).
•Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug-eluting coronary stent implantation).
•Blood dyscrasias as defined: leukopenia (WBC\<3000 mm3), acute anemia (Hb\<9 mg%), thrombocytopenia (platelet count \<50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
•Untreated clinically significant coronary artery disease requiring revascularization.
•Need for emergency surgery for any reason.
•Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
•Active bacterial endocarditis or other active infections.
•Active peptic ulcer or upper GI bleeding within the prior 3 months.
•A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
•Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).