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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02351726
Other study ID # TMT001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source LivaNova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The purpose of this clinical investigation is to evaluate the safety and efficacy of the Mitroflow DL valve when used to replace diseased or dysfunctional native or prosthetic aortic heart valves. The study will be conducted in a minimum of 15 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, at 1 year (between 11 and 13 months postoperatively), and annually for 8 years. The duration of the study is anticipated to be 8 years.


Recruitment information / eligibility

Status Terminated
Enrollment 186
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU).

2. Patient or patient's legal representative is willing to sign the informed consent.

3. Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement

4. 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

5. Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable).

Exclusion Criteria:

1. Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use.

2. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position.

3. Patient requires a double or triple valve replacement (repair is not considered an exclusion).

4. Patient has active endocarditis or myocarditis.

5. Patient is pregnant or lactating.

6. Patient is participating in a concomitant research study of an investigational product.

Study Design


Intervention

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

Locations

Country Name City State
United States Bay Regional Medical Center Bay City Michigan
United States Suburban Hospital - John Hopkins Medicine Bethesda Maryland
United States University of Virginia Medical Center Charlottesville Virginia
United States St. John Hospital & Medical Center Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States River City Clinical Research Jacksonville Florida
United States UF Health - Jacksonville Jacksonville Florida
United States Watson Clinic Center for Research Lakeland Florida
United States UCLA Medical Center Los Angeles California
United States Catholic Medical Center Manchester New Hampshire
United States St. Joseph's Regional Medical Center Paterson New Jersey
United States Sharp Memorial Hospital San Diego California
United States Lankenau Medical Center Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
LivaNova

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of structural Valve Deterioration in Implanted Patients To establish rates of structural valve deterioration through 8 years follow-up 8 years
Secondary Early and Late Valve-Related Adverse Event Rates To determine early and late valve-related adverse event rates, including valve thrombosis, thromboembolism, paravalvular leak (all and major), bleeding(all and major), and endocarditis, for Mitroflow DL are comparable to appropriate historical controls Early (30 days) and Late (> 30 days)
Secondary Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related) Early (30 days) and Late (> 30 days)
Secondary Hemodynamic Performance To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature 8 years
Secondary Improvements in NYHA To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification 8 years
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