Mitroflow DL Post Approval Study- North America

Not Applicable

Terminated

• Conditions: Aortic Regurgitation; Heart Valve Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Aortic Stenosis; Aortic Valve Insufficiency; Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases
• Interventions: Device: Mitroflow DL

• Registration Number: NCT02351726
• Lead Sponsor: LivaNova

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-30
• Study Start: 2015-03
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 186

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of structural Valve Deterioration in Implanted Patients	8 years	To establish rates of structural valve deterioration through 8 years follow-up

Secondary Outcome Measures

Name	Time	Method
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)	To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related)
Improvements in NYHA	8 years	To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification
Early and Late Valve-Related Adverse Event Rates	Early (30 days) and Late (> 30 days)	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
Hemodynamic Performance	8 years	To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature

Trial Locations

Locations (13)

Catholic Medical Center; 🇺🇸 Manchester, New Hampshire, United States

Bay Regional Medical Center; 🇺🇸 Bay City, Michigan, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

River City Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

UF Health - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Watson Clinic Center for Research; 🇺🇸 Lakeland, Florida, United States

Suburban Hospital - John Hopkins Medicine; 🇺🇸 Bethesda, Maryland, United States

St. John Hospital & Medical Center; 🇺🇸 Detroit, Michigan, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States

St. Joseph's Regional Medical Center; 🇺🇸 Paterson, New Jersey, United States