Aortic StenosisNCT02351726
Mitroflow DL Post Approval Study- North America
A study testing Mitroflow DL in people with Aortic Stenosis and Aortic Regurgitation, run by LivaNova at 13 sites in United States.
Trial summary
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency
- What is being tested?
- Mitroflow DL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Bay Regional Medical Center
Bay City, Michigan, 48708
Suburban Hospital - John Hopkins Medicine
Bethesda, Maryland, 20814
University of Virginia Medical Center
Charlottesville, Virginia, 22908
St. John Hospital & Medical Center
Detroit, Michigan, 48236
Duke University Medical Center
Durham, North Carolina, 27710
River City Clinical Research
Jacksonville, Florida, 32207
UF Health - Jacksonville
Jacksonville, Florida, 32209
Watson Clinic Center for Research
Lakeland, Florida, 33805
UCLA Medical Center
Los Angeles, California, 90095
Catholic Medical Center
Manchester, New Hampshire, 03102
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Sharp Memorial Hospital
San Diego, California, 92123
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
Read the 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.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases, Cardiovascular Abnormalities, Cardiovascular Diseases
- Being tested
- Mitroflow DL
- Keywords
- aortic valve replacement, aortic stenosis, aortic steno-insufficiency
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases, Cardiovascular Abnormalities, Cardiovascular Diseases, Congenital Abnormalities, Heart Diseases, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitroflow DLDevice
Also called Mitroflow Pericardial Aortic Heart Valve with PRT
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
| Study group | Role | What they receive |
|---|---|---|
| Mitroflow DL | Experimental | Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL) Receives: Device: Mitroflow DL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of structural Valve Deterioration in Implanted Patients
To establish rates of structural valve deterioration through 8 years follow-up
Measured: 8 years
Secondary outcomes (4)
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
Measured: Early (30 days) and Late (> 30 days)
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)
Measured: Early (30 days) and Late (> 30 days)
Hemodynamic Performance
To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature
Measured: 8 years
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
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Sponsor business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Kern, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351726
- Sponsor's protocol ID
- TMT001
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2015
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
- ClinicalTrials.gov ID
- NCT02351726
- Acronym / sponsor ID
- TMT001
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases, Cardiovascular Abnormalities, Cardiovascular Diseases
- Keywords
- aortic valve replacement, aortic stenosis, aortic steno-insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision
- Enrolment
- 186 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitroflow DL | Experimental | Device: Mitroflow DLTreatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitroflow DLAlso: Mitroflow Pericardial Aortic Heart Valve with PRTTreatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL) | Device | Mitroflow DL |
Primary outcome
Rate of structural Valve Deterioration in Implanted Patients
Time frame: 8 years
To establish rates of structural valve deterioration through 8 years follow-up
4 secondary outcomes
Early and Late Valve-Related Adverse Event Rates
Time frame: Early (30 days) and Late (> 30 days)
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)
Hemodynamic Performance
Time frame: 8 years
Improvements in NYHA
Time frame: 8 years
Results and safety
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kern, MD principal investigator
University of Virginia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitroflow DL in people with Aortic Stenosis and Aortic Regurgitation, run by LivaNova at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of structural Valve Deterioration in Implanted Patients (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.