NCT01437098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

February 15, 2019

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

September 16, 2011

Results QC Date

October 2, 2015

Last Update Submit

January 31, 2019

Conditions

Aortic Valve Stenosis

Keywords

Valvular Heart DiseaseSevere Aortic StenosisAortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).

    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.

    baseline and 6 months

Secondary Outcomes (47)

  • NYHA Classification Over Time

    30 days

  • NYHA Classification Over Time

    6 months

  • NYHA Classification Over Time

    12 Months

  • NYHA Classification Over Time

    24 Months

  • NYHA Classification Over Time

    36 Months

  • +42 more secondary outcomes

Study Arms (1)

MDT-2111 CoreValve TAVI

EXPERIMENTAL

Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 CoreValve system. Access sites for the implant include: Iliofemoral, Subclavian and Direct Aortic.

Device: MDT-2111 CoreValve for TAVI

Interventions

MDT-2111 CoreValve for TAVIDEVICE

CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.

MDT-2111 CoreValve TAVI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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:
  • +38 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Saitama Medical University

Hidaka, Saitama, 350-1298, Japan

Location

Related Publications (2)

  • 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: 28321003DERIVED

  • Sawa Y, Saito S, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Boyle A, Zhang A, Moore BJ, de Medeiros R; MDT-2111 Japan Investigators. First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis. Circ J. 2014;78(5):1083-90. doi: 10.1253/circj.cj-14-0162. Epub 2014 Mar 21.

    PMID: 24662399DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Results Point of Contact

Title
Hiroko Ookubo
Organization
Medtronic
hiroko.ookubo@medtronic.com
81367760811

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

September 16, 2011

First Posted

September 20, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2013

Study Completion

November 27, 2018

Last Updated

February 15, 2019

Results First Posted

June 6, 2016

Record last verified: 2018-10

Locations

JP(4)