Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis

Medtronic Cardiovascular4 sites in 1 country55 target enrollmentOctober 2011

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Medtronic Cardiovascular
Enrollment: 55
Locations: 4
Primary Endpoint: Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

Non-randomized, prospective, multicenter, single-arm trial.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

November 27, 2018

Last Updated

7 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 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.
•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.
•Subject has been informed of the nature of the trial and has signed an Informed Consent Form.
•Subject 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 Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).

Time Frame: baseline and 6 months

The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.

Secondary Outcomes

NYHA Classification Over Time(36 Months)
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)(0 day to 36 months)
Valve-related Deaths(0 day to 36 months)
Device Success as Defined in the Description.(after procedure or discharge)
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)(36 months)
Valve-Related Deaths(0 day to 12 months)
Repeat Hospitalization(0 day to 36 months)
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)(Baseline to 36 Months)
Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.(after procedure or discharge)
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient(36 months)
Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient(6 months)
Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)(36 months)
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)(36 months)