Mitroflow DL Post Approval Study- North America

Cardiovascular Diseases Clinical Trial

Official title:

Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02351726
• Other study ID #: TMT001
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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