Mitroflow DL Post Approval Study- North America

Sponsor

LivaNova (Industry)

Overall Status

Terminated

CT.gov ID

NCT02351726

Collaborator

(none)

186

Enrollment

Locations

Arm

Actual Duration (Months)

14.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis Aortic Regurgitation Aortic Valve Insufficiency Heart Valve Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Diseases Pathological Conditions, Anatomical	Device: Mitroflow DL	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mitroflow DL Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)	Device: Mitroflow DL Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL) Other Names: Mitroflow Pericardial Aortic Heart Valve with PRT

Arm

Intervention/Treatment

Experimental: Mitroflow DL

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

Device: Mitroflow DL

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

Other Names:

Mitroflow Pericardial Aortic Heart Valve with PRT

Outcome Measures

Primary Outcome Measures

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

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
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)
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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 requires a double or triple valve replacement (repair is not considered an exclusion).
Patient has active endocarditis or myocarditis.
Patient is pregnant or lactating.
Patient is participating in a concomitant research study of an investigational product.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90095
2	Sharp Memorial Hospital	San Diego	California	United States	92123
3	River City Clinical Research	Jacksonville	Florida	United States	32207
4	UF Health - Jacksonville	Jacksonville	Florida	United States	32209
5	Watson Clinic Center for Research	Lakeland	Florida	United States	33805
6	Suburban Hospital - John Hopkins Medicine	Bethesda	Maryland	United States	20814
7	Bay Regional Medical Center	Bay City	Michigan	United States	48708
8	St. John Hospital & Medical Center	Detroit	Michigan	United States	48236
9	Catholic Medical Center	Manchester	New Hampshire	United States	03102
10	St. Joseph's Regional Medical Center	Paterson	New Jersey	United States	07503
11	Duke University Medical Center	Durham	North Carolina	United States	27710
12	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
13	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908