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

NCT01634269 | Completed Results DMC

• 1 other identifier: MDT-2111 23 mm trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Aortic Valve Stenosis

Keywords

Valvular Heart Disease; Severe Aortic Stenosis; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline and 6 months

Secondary Outcomes (38)

• New York Heart Classification (NYHA) Over Time

  30 days

• New York Heart Classification (NYHA) Over Time

  6 months

• New York Heart Classification (NYHA) Over Time

  12 months

• New York Heart Classification (NYHA) Over Time

  24 months

• Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)

  0 day to 30 days

Study Arms (1)

MDT-2111 TAVI 23 mm

EXPERIMENTAL

Subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention.

Device: MDT-2111 TAVI 23 mm

Interventions

MDT-2111 TAVI 23 mm DEVICE

Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.

MDT-2111 TAVI 23 mm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram.
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack(TIA).
• End stage renal disease requiring chronic dialysis.
• GI bleeding within the past 3 months.
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (4)

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Saitama Medical University

Hidaka, Saitama, Japan

Location

Related Publications (1)

• Sawa Y, Torikai K, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Zhang A, Saito S. Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis. Circ J. 2017 Jul 25;81(8):1108-1115. doi: 10.1253/circj.CJ-17-0112. Epub 2017 Mar 17.

  PMID: 28321003 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Hiroko Ookubo
• Organization: Medttronic

hiroko.ookubo@medtronic.com

81367760811

Study Officials

• Yoshi Sawa, Professor

  Osaka University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2019
• Last Updated: October 15, 2019
• Results First Posted: December 17, 2018

Record last verified: 2019-10

Locations

JP (4)