NCT02738853

Brief Summary

The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

8 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

Study Start

First participant enrolled

April 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 8, 2018

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

April 11, 2016

Results QC Date

November 21, 2017

Last Update Submit

March 17, 2023

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (3)

  • All-cause Mortality Rate

    30 days

  • Stroke (Disabling) Rate

    30 days

  • The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram

    30 days

Secondary Outcomes (10)

  • Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:

    30 days

  • Percentage of Participants With Life Threatening or Disabling Bleeding

    30 days

  • Percentage of Participants With Major Vascular Complication

    30 days

  • Percentage of Participants With Coronary Artery Obstruction

    30 days

  • Percentage of Patient With Acute Kidney Injury- Stage 2 or 3

    30 days

  • +5 more secondary outcomes

Study Arms (1)

Medtronic Transcatheter Aortic Valve 2.0 Replacement System

EXPERIMENTAL

Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System

Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Interventions

Medtronic Transcatheter Aortic Valve 2.0 Replacement SystemDEVICE

Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Eligibility Criteria

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

You may qualify if:

  • Severe aortic stenosis, defined as aortic valve area of \<1.0 cm2 (or aortic valve area index of \<0.6 cm2/m2) by the continuity equation, AND mean gradient \>40 mmHg OR maximal aortic valve velocity \>4.0 m/sec by resting echocardiogram
  • Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
  • Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
  • The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

You may not qualify if:

  • Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
  • aspirin or heparin (HIT/HITTS) and bivalirudin
  • ticlopidine and clopidogrel
  • nitinol (titanium or nickel)
  • contrast media
  • Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
  • End stage renal disease requiring chronic dialysis or creatinine clearance \<20 cc/min.
  • Ongoing sepsis, including active endocarditis
  • Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  • Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

NYU / Langone Medical Center

New York, New York, 10016, United States

Location

New York-Presbyterian Hospital / Columbia University Medical Center

New York, New York, 10032, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16. doi: 10.1016/j.carrev.2020.11.007. Epub 2020 Nov 10.

    PMID: 33199247DERIVED

  • Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.

    PMID: 29348010DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Phuong-Uyen Le
Organization
Medtronic
phuong-uyen.n.le@medtronic.com
763-526-0989

Study Officials

  • John Forrest, MD

    Yale New Haven Hospital

    PRINCIPAL INVESTIGATOR

  • Mathew Williams, MD

    NYU Langone Medical Center

    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

April 11, 2016

First Posted

April 14, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 15, 2021

Last Updated

March 21, 2023

Results First Posted

February 8, 2018

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(8)