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

Primary Purpose

Aortic Valve, Aortic Valve Insufficiency, Aortic Regurgitation

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TAVR with Evolut R valve
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve focused on measuring TAVR, TAVI, Pure AR

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pure AR

Arm Description

Patients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement.

Outcomes

Primary Outcome Measures

Aortic regurgitation

Secondary Outcome Measures

All cause death
Cardiovascular mortality
Stroke
Valve Academic Research Consortium (VARC)
Myocardial Infarction
Valve Academic Research Consortium (VARC)
Re-hospitalization
Acute kidney injury
Valve Academic Research Consortium (VARC)
Vascular access site and access-related complication
Valve Academic Research Consortium (VARC)
Bleeding
Valve Academic Research Consortium (VARC)
Acute kidney injury

Full Information

First Posted
June 25, 2018
Last Updated
February 21, 2019
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03578952
Brief Title
Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation
Acronym
Pure AR TAVR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
End of support
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve, Aortic Valve Insufficiency, Aortic Regurgitation, Regurgitation, Aortic Valve, Aortic Incompetence
Keywords
TAVR, TAVI, Pure AR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pure AR
Arm Type
Experimental
Arm Description
Patients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement.
Intervention Type
Device
Intervention Name(s)
TAVR with Evolut R valve
Intervention Description
TAVR with Evolut R valve
Primary Outcome Measure Information:
Title
Aortic regurgitation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
All cause death
Time Frame
1 month, 6 months, 1,2,3 and 5 years
Title
Cardiovascular mortality
Time Frame
1 month, 6 months, 1,2,3 and 5 years
Title
Stroke
Description
Valve Academic Research Consortium (VARC)
Time Frame
1 month, 6 months, 1,2,3 and 5 years
Title
Myocardial Infarction
Description
Valve Academic Research Consortium (VARC)
Time Frame
1 month, 6 months, 1,2,3 and 5 years
Title
Re-hospitalization
Time Frame
1 month, 6 months, 1,2,3 and 5 years
Title
Acute kidney injury
Description
Valve Academic Research Consortium (VARC)
Time Frame
7 days
Title
Vascular access site and access-related complication
Description
Valve Academic Research Consortium (VARC)
Time Frame
7 days
Title
Bleeding
Description
Valve Academic Research Consortium (VARC)
Time Frame
7 days
Title
Acute kidney injury
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 ≥8. 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). Life expectancy < 12 months due to non-cardiac comorbid conditions. 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). Root disease including annuloaortic ectasia or aneurysm of root or sinus. 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). Pregnant(positive result from pregnancy test conducted during screening visit and within prior 2 weeks of valve replacement) or lactating women.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation

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