Mitral Valve RegurgitationMAARSNCT00554151
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
A study testing Adjustable Annuloplasty Ring in people with Mitral Valve Regurgitation, run by Abbott Medical Devices at 5 sites in 3 countries.
Trial summary
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Adjustable Annuloplasty Ring
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2007to Apr 2010
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged greater or equal to 18 to less than or equal to age 75.
- Patients with indications to undergo mitral valve repair consistent with ACC/AHA recommendations; including greater or equal to 2+ regurgitation by pre-operative TEE or TTE assessment.
- Candidate for cardiopulmonary bypass.
- A Left Ventricular Ejection Fraction greater or equal to 40%.
- Able and willing to comply with all study requirements, including the required study follow-up visits.
- Able and willing to five consent and follow study instructions.
- Female patients of childbearing potential (not surgically sterilized or more than one year postmenopausal), with a negative pregnancy test (serum beta-hCG) within 24 hours prior to mitral valve surgery.
Who cannot join
- Any previous cardiac surgery.
- Any interventional cardiology procedure within six months prior to study to include all patients that have had a drug eluting stent (DES) implanted within 6 months.
- Evidence of an acute Myocardial Infarction (MI) within 7 days of the intended treatment with the investigational device.
- Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.
- Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
- Recent or evolving bacterial endocarditis or patients under current antibiotic therapy.
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- Patients with ICD's.
- Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the placement of the device or concurrent medical condition with a life expectancy of less than 12 months.
- Patients who are immunocompromised or with autoimmune diseases.
- Patients suffering from renal insufficiency (Creatinine >2.5 mg/dL) or patients with chronic renal failure undergoing dialysis.
- Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. sever chronic obstructive pulmonary disease, hepatic failure, immunosuppressive abnormalities, haematological abnormalities).
- Significant mitral annular calcification.
- Use of Coumadin, IIbIIIa inhibitors, Clopidigrel (Plavix) or other anti-coagulants within (5) five days prior to surgery.
- Participation in any study involving an investigational drug or device within the past month, or ongoing participation in a study with an investigational device.
- Intolerance or hypersensitivity to anaesthetics.
- Patients in whom transesophageal echo/Doppler is contraindicated.
- History of bleeding diathesis or coagulopathy.
- History of stroke within the prior 6 months
- Subjects to undergo concomitant cardiac repair or replacement other than CABG (less than or equal to 3 vessels) mitral annuloplasty, tricuspid valve repair and ablation therapy for correction of atrial fibrillation. Excluded concomitant procedures are: aortic valve replacement, LV remodeling, surgery and congenital repair.
- Patients with Euroscore > 10.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany2 sites
Herz - und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, Saale, 97615
University Leipzig
Leipzig
Netherlands2 sites
Leids Universitair Medisch Centrum
Leiden
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam
About this study
Official title: Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
Read the detailed description
Establish the technical feasibility and safety of implantation of the investigation device, adjustment of the investigational device post-implantation, and the ability of the investigational device to reduce mitral valve regurgitation.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Adjustable Annuloplasty Ring
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Annuloplasty RingDevice
The investigational device is intended for use in the treatment of mitral valve regurgitation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.
Measured: 30 days, 90 days, 6 months and 1 year
Secondary outcomes (1)
Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB. MR reduction to <2+ post procedure, at post operative hospital discharge, at 30 days, at 6 months and one year.
Measured: 30 days, 90 days, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A. Franka Borger, Prof. MD, Principal investigator, University Leipzig GermanyA.P. Kappetein, Dr., Principal investigator, Erasmus MC, Universitair Medisch Centrum RotterdamR.J.M. Klautz, Dr., Principal investigator, Leids Universitair Medisch Centrum LiedenAnno Diegeler, Prof, MD, Principal investigator, Herz-und Gefäß-Klinik GmbH Bad NeustadtOttavio Alfieri, Prof, MD, Principal investigator, Hospital San Rafaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554151
- Sponsor's protocol ID
- MAARS CIP Version 5
- Acronym
- MAARS
- Status last verified
- Feb 2019
- First submitted
- 2 Nov 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair
- ClinicalTrials.gov ID
- NCT00554151
- Acronym / sponsor ID
- MAARS / MAARS CIP Version 5
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Nov 2007 (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.
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
Detailed description
Establish the technical feasibility and safety of implantation of the investigation device, adjustment of the investigational device post-implantation, and the ability of the investigational device to reduce mitral valve regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females aged greater or equal to 18 to less than or equal to age 75.
- Patients with indications to undergo mitral valve repair consistent with ACC/AHA recommendations; including greater or equal to 2+ regurgitation by pre-operative TEE or TTE assessment.
- Candidate for cardiopulmonary bypass.
- A Left Ventricular Ejection Fraction greater or equal to 40%.
- Able and willing to comply with all study requirements, including the required study follow-up visits.
Key exclusion criteria (20 listed)
- Any previous cardiac surgery.
- Any interventional cardiology procedure within six months prior to study to include all patients that have had a drug eluting stent (DES) implanted within 6 months.
- Evidence of an acute Myocardial Infarction (MI) within 7 days of the intended treatment with the investigational device.
- Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.
- Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
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 |
|---|---|---|
| Adjustable Annuloplasty RingThe investigational device is intended for use in the treatment of mitral valve regurgitation. | Device | – |
Primary outcome
Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.
Time frame: 30 days, 90 days, 6 months and 1 year
1 secondary outcome
Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB. MR reduction to <2+ post procedure, at post operative hospital discharge, at 30 days, at 6 months and one year.
Time frame: 30 days, 90 days, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Related trials for Mitral Valve Regurgitation
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
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.
A. Franka Borger, Prof. MD principal investigator
University Leipzig Germany
A.P. Kappetein, Dr. principal investigator
Erasmus MC, Universitair Medisch Centrum Rotterdam
R.J.M. Klautz, Dr. principal investigator
Leids Universitair Medisch Centrum Lieden
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Annuloplasty Ring in people with Mitral Valve Regurgitation, run by Abbott Medical Devices at 5 sites in 3 countries.
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 7 inclusion and 20 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device. (time frame: 30 days, 90 days, 6 months and 1 year). 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 4 Feb 2019.