Medtronic MDT-2111 CoreValve Japan 23mm Study

Medtronic Cardiovascular4 sites in 1 country20 target enrollmentJuly 2012

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Medtronic Cardiovascular
Enrollment: 20
Locations: 4
Primary Endpoint: Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA).
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.

Detailed Description

The purpose of this trial is to evaluate the effectiveness and safety of the MDT-2111 TAV system in subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention. The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 New York Heart Association (NYHA) class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must have co-morbidities such that one cardiologist and one cardiac surgeon agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement.
•Subject has senile degenerative aortic valve stenosis with:
•mean gradient \> 40 mmHg or jet velocity greater than 4.0 m/s by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm² (or aortic valve area index ≤ 0.5 cm²/m²) by resting echocardiogram.
•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class Class III or greater. If screening committee agrees the eligibility of a patient with class II , based on medical factors, he/she can be enrolled.
•Patient has been informed of the nature of the trial and has signed an Informed Consent Form.
•Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.

Exclusion Criteria

•Evidence of an acute myocardial infarction ≤ 30 days prior to the intended treatment.
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the procedure.
•Blood dyscrasias as defined:
•Leukopenia (WBC count \< 1,000 cells/mm³)
•Thrombocytopenia (platelet count \<50,000 cells/mm³)
•History of bleeding diathesis or coagulopathy
•Hypercoagulable states
•Untreated clinically significant coronary artery disease requiring revascularization.
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
•Need for emergency surgery for any reason.

Outcomes

Primary Outcomes

Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA).

Time Frame: baseline and 6 months

The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.

Secondary Outcomes

Repeat Hospitalization(0 day to 24 months)
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)(0 day to 24 months)
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)(24 months)
Valve-related Deaths(0 day to 24 months)
Device Success as Defined in the Description.(after procedure or discharge)
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)(24 months)
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient(24 months)
New York Heart Classification (NYHA) Over Time(24 months)
Procedural Success, Defined as Device Success and Absence of In-hospital MACCE(from admission for procedure to discharge)
Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)(24 months)
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)(Baseline to 24 months)