Mitroflow DL Post Approval Study- North America

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02351726
• Date of registration: 22/01/2015
• Prospective Registration: Yes
• Primary sponsor: LivaNova
• Public title: Mitroflow DL Post Approval Study- North America
• Scientific title: Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
• Date of first enrolment: March 2015
• Target sample size: 186
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02351726
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: John Kern, MD
• Affiliation: University of Virginia

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Pathological Conditions, Anatomical

Aortic Stenosis

Cardiovascular Abnormalities

Aortic Regurgitation

Aortic Valve Insufficiency

Congenital Abnormalities

Heart Valve Diseases

Heart Diseases

Intervention(s)

Device: Mitroflow DL

Primary Outcome(s)

Rate of structural Valve Deterioration in Implanted Patients [Time Frame: 8 years]

Secondary Outcome(s)

Early and Late Valve-Related Adverse Event Rates [Time Frame: Early (30 days) and Late (> 30 days)]

Hemodynamic Performance [Time Frame: 8 years]

Improvements in NYHA [Time Frame: 8 years]

Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death [Time Frame: Early (30 days) and Late (> 30 days)]

Secondary ID(s)

TMT001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors