Clinical trial NCT02351726: Mitroflow DL Post Approval Study- North America
Official title: Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Stenosis
Aortic Regurgitation
Aortic Valve Insufficiency
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Pathological Conditions, Anatomical
Keywords: aortic valve replacement
aortic stenosis
aortic steno-insufficiency
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Rate of structural Valve Deterioration in Implanted Patients
timeFrame: 8 years
Secondary outcomes:
measure: Early and Late Valve-Related Adverse Event Rates
timeFrame: Early (30 days) and Late (> 30 days)
measure: Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death
timeFrame: Early (30 days) and Late (> 30 days)
measure: Hemodynamic Performance
timeFrame: 8 years
measure: Improvements in NYHA
timeFrame: 8 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: UF Health - Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research
state: Florida
city: Bethesda
country: United States
facility: Suburban Hospital - John Hopkins Medicine
state: Maryland
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: John Kern, MD
role: PRINCIPAL_INVESTIGATOR
References: