Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

NCT03635424 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 10790330DOC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 25

Brief Summary

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Conditions

Bicuspid Aortic Valve

Outcome Measures

Primary Outcomes (2)

• Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.

  Rate of of all-cause mortality or disabling stroke rate at 30 days

  30 days

• Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.

  Device success rate, defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

  7 days

Secondary Outcomes (18)

• All-Cause Mortality Rate

  1 year and annually through 10 years

• All Stroke (Disabling and Non-Disabling) Rate

  1 year and annually through 10 years

• Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.

  30 days

• Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure.

  30 days

• Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.

  30 days

Study Arms (1)

Medtronic TAVR Systems

EXPERIMENTAL

Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems

Device: Medtronic TAVR Systems

Interventions

Medtronic TAVR Systems DEVICE

Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems

Medtronic TAVR Systems

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe aortic stenosis, defined as follows:
• For symptomatic patients:
• Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest
• For asymptomatic patients:
• Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
• Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
• Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%.
• Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR \<3% at 30 days per multidisciplinary local heart team assessment.
• Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.
• 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).
• Age less than 60 years
• A known hypersensitivity or contraindication to any of the following that 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.
• Ongoing sepsis, including active endocarditis.
• Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.
• Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery.
• 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 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Gastrointestinal (GI) bleeding that would preclude anticoagulation.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (25)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

Location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

HealthPark Medical Center

Fort Myers, Florida, 33908, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health Hospital

Grand Rapids, Michigan, 49503, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Saint Francis Hospital

Roslyn, New York, 11576, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States

Location

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, 17101, United States

Location

Paramount Heart

Villanova, Pennsylvania, 19085, United States

Location

Baylor Jack and Jane Hamilton Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• Forrest JK, Ramlawi B, Deeb GM, Zahr F, Song HK, Kleiman NS, Chetcuti SJ, Michelena HI, Mangi AA, Skiles JA, Huang J, Popma JJ, Reardon MJ. Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis. JAMA Cardiol. 2021 Jan 1;6(1):50-57. doi: 10.1001/jamacardio.2020.4738.

  PMID: 33031491 DERIVED

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Hatice Bilgic Lim, PhD; Principal Clinical Research Specialist
• Organization: Medtronic Coronary and Structural Heart Clinical

hatice.bilgic.lim@medtronic.com

763-526-1018

Study Officials

• Michael Reardon, MD

  The Methodist Hospital Research Institute

  STUDY CHAIR

• John Forrest, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Basel Ramlawi, MD

  Paramount Heart

  PRINCIPAL INVESTIGATOR

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: July 31, 2018
• First Posted: August 17, 2018
• Study Start: October 30, 2018
• Primary Completion: November 13, 2019
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 5, 2026
• Results First Posted: December 21, 2020

Record last verified: 2026-04

Locations

US (25)