Mitroflow DL Post Approval Study- North America

NCT02351726 | Terminated DMC

• 1 other identifier: TMT001
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 13

Brief Summary

Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.

Conditions

Aortic Stenosis; Aortic Regurgitation; Aortic Valve Insufficiency; Heart Valve Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Heart Diseases; Pathological Conditions, Anatomical

Keywords

aortic valve replacement; aortic stenosis; aortic steno-insufficiency

Outcome Measures

Primary Outcomes (1)

• Rate of structural Valve Deterioration in Implanted Patients

  To establish rates of structural valve deterioration through 8 years follow-up

  8 years

Secondary Outcomes (4)

• Early and Late Valve-Related Adverse Event Rates

  Early (30 days) and Late (> 30 days)

• Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death

  Early (30 days) and Late (> 30 days)

• Hemodynamic Performance

  8 years

• Improvements in NYHA

  8 years

Study Arms (1)

Mitroflow DL

EXPERIMENTAL

Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)

Device: Mitroflow DL

Interventions

Mitroflow DL DEVICE

Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)

Also known as: Mitroflow Pericardial Aortic Heart Valve with PRT

Mitroflow DL

Eligibility Criteria

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

You may qualify if:

• Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU).
• Patient or patient's legal representative is willing to sign the informed consent.
• Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement
• Any patient amenable to aortic valve replacement with a biological prosthesis should be enrolled in the study, even in conjuction with valve repair, coronary artery bypass grafting and other procedures
• Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable).

You may not qualify if:

• Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use.
• The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position.
• Patient has active endocarditis or myocarditis.
• Patient is pregnant or lactating.
• Patient is participating in a concomitant research study of an investigational product.

Sponsors & Collaborators

• LivaNova: lead

Study Sites (13)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

UF Health - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Watson Clinic Center for Research

Lakeland, Florida, 33805, United States

Location

Suburban Hospital - John Hopkins Medicine

Bethesda, Maryland, 20814, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

St. Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Heart Diseases; Pathological Conditions, Anatomical

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Ventricular Outflow Obstruction; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms

Study Officials

• John Kern, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

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: January 22, 2015
• First Posted: January 30, 2015
• Study Start: March 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

US (13)