Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation (Pure AR TAVR)

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

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).

Study Overview

• Status: Terminated
• Conditions: Aortic Regurgitation; Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve; Aortic Incompetence
• Intervention / Treatment: Device: TAVR with Evolut R valve

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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 ≥8. In this case, all evidence must be documented in the study case report form as well as in the patient medical record.

2. There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline.
3. The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
4. 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.
5. The subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography.
6. The subject agrees that the subject will cooperate with study team for all required post-procedure visits.
7. The subject's age is 20 or more.

Exclusion Criteria:

1. 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).
2. 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).
3. 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.
4. Untreated clinically significant coronary artery disease requiring revascularization.
5. Need for emergency surgery for any reason.
6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
7. Active bacterial endocarditis or other active infections.
8. Active peptic ulcer or upper GI bleeding within the prior 3 months.
9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
10. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
11. Life expectancy < 12 months due to non-cardiac comorbid conditions.
12. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend or angle of aortic arch ≥200 degree),aortic arch atheroma (especially if thick [> 5mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only).
13. Root disease including annuloaortic ectasia or aneurysm of root or sinus.
14. Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity(with moderate or severe calcification and two or more severe curve (angle ≥90°) (applicable for transfemoral patients only).
15. Pregnant(positive result from pregnancy test conducted during screening visit and within prior 2 weeks of valve replacement) or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pure AR; Patients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement.	Device: TAVR with Evolut R valve; TAVR with Evolut R valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aortic regurgitation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death		1 month, 6 months, 1,2,3 and 5 years
Cardiovascular mortality		1 month, 6 months, 1,2,3 and 5 years
Stroke	Valve Academic Research Consortium (VARC)	1 month, 6 months, 1,2,3 and 5 years
Myocardial Infarction	Valve Academic Research Consortium (VARC)	1 month, 6 months, 1,2,3 and 5 years
Re-hospitalization		1 month, 6 months, 1,2,3 and 5 years
Acute kidney injury	Valve Academic Research Consortium (VARC)	7 days
Vascular access site and access-related complication	Valve Academic Research Consortium (VARC)	7 days
Bleeding	Valve Academic Research Consortium (VARC)	7 days
Acute kidney injury		7 days

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): February 21, 2019
• Study Completion (Actual): February 21, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Pure AR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: AMCCV2018-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No