Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Freedom from device related major adverse events (MAE) at 30 days.
Performance: Technical success rate of implantation of the investigational
device.
Secondary outcome
Performance:
Ability to adjust the investigational device post-ring implantation after the
patient has been weaned from CPB
MR reduction post-procedure at post-operative hospital discharge, 30 days and
at 90 days
Background summary
Multicenter study to assess the safety and performance of the device for the
purpose of obtaining the CE Mark.
Study objective
Establish the technical feasibility and safety of implantation of the
investigational device, adjustment of the investigational device
post-implantation and the ability of the investigational device to reduce
mitral valve regurgitation.
Study design
single arm, prospective
Intervention
Surgicall implanted device.
Study burden and risks
Risks:
*Death
*Myocardial infarction
*Stroke/ transient ischemic attack
*Hemolysis
*Heart block
*Perforation or damage of vessels, myocardium or valvular structures
*Pericardial effusion/cardiac tamponade
*Haematoma
*Blood loss requiring transfusion
*Infection including endocarditis and septicaemia
*Arrhythmia
*Air embolus
*Thromboembolism
*Fever
*Hypertension/hypotension
*Allergic dye reaction
*Anaesthesia reactions
In addition to the risks listed above, the potential risks specifically
associated with the mitral valve annuloplasty procedures include, but may not
be limited to, the following:
*Device dehiscence resulting in residual mitral regurgitation
*Systolic Anterior Motion
*Left Ventricular Outflow Tract Obstruction
*Residual or recurrent valvular insufficiency requiring intervention
*Coronary occlusion of the left circumflex artery (LCX) from suturing the
device to the valve resulting in myocardial infarction (MI)
*Annular ventricular dehiscence leading to ventricular rupture
In addition to the risks associated to the annuloplasty procedure in general,
risks associated specifically to the MitralSolutions Adjustable annuloplasty
system include, but may not be limited to the following:
*Unsuccessful adjustment of the ring size
*Suture distortion or pull-out due to device adjustment placing stress on
suture points
*Tissue damage from insertion and removal of the adjustment tool
Benefits:
The proposed product and surgical procedure are aimed at benefiting the
patients physically as well as emotionally. Although there are no guaranteed
benefits from participation in this study, it is possible that treatment with
the MitralSolutions Adjustable Annuloplasty Ring will provide the potential for
fewer clinical complications resulting from inadequate sizing of the annulus
associated with standard annuloplasty rings on the market.
Mitral valve repair using MitralSolutions annuloplasty system emulates the same
technique used by conventional non-adjustable annuloplasty rings. The
reduction of the septal-lateral annular dimension is the primary mechanism used
by current annuloplasty rings/systems whose focus is treating ischemic or
functional mitral regurgitation, however, currently available rings are not
adjustable and require the availability of multiple ring sizes. Unlike
currently marketed rings which do not allow for adjustment after implant or
weaning from CPB, the MitralSolutions annuloplasty system offers the clinician
the opportunity to make adjustments to minimize or eliminate residual
regurgitation (or possibly, systolic anterior motion of the mitral valve) after
weaning from CPB using a titanium mechanical gear system that reduces the
septal-lateral (S-L) dimension of the mitral valve with precision. With
conventional annuloplasty rings, if moderate residual mitral regurgitation is
present after implant, a re-repair requires the patient to be placed back on
CPB. The annuloplasty ring is then removed and replaced with a different size
or configuration ring; often, the native mitral valve is replaced with a
prosthetic valve.
The adjustability feature of the MitralSolutions annuloplasty system ring may
reduce the number of patients leaving the operating room with mild to moderate
residual mitral regurgitation after mitral valve repair, since further
reduction of the S-L annular dimension can be made under TEE guidance after
weaning from CPB. The MitralSolutions annuloplasty system may offer a
potentially safer procedure compared to conventional mitral annuloplasty
techniques by reducing the likelihood that a patient would need a re-repair or
replacement of the valve due to residual mitral regurgitation stemming from
initial inaccurate sizing and fit of an annuloplasty ring to the mitral valve.
1700 East Las Olas Blvd., Suite 203
Fort Lauderdale, FL 33301
United States
1700 East Las Olas Blvd., Suite 203
Fort Lauderdale, FL 33301
United States
Listed location countries
Age
Inclusion criteria
Males or females aged *18 to *75 years. ;Patients with *Grade 2+ mitral regurgitation by pre-operative Trans-Thoracic Echo assessment.;Candidate for cardiopulmonary bypass. ;A Left Ventricular Ejection Fraction *40%. ;Able and willing to comply with all study requirements, including the required study follow-up visits. ;Able and willing to give 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.
Exclusion criteria
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.;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 surgical repair or replacement other than CABG (3 vessels or less) and mitral annuloplasty. Excluded concomitant procedures are: aortic valve replacement, tricuspid repair or replacement, left ventricular remodelling surgery and congenital repair.;Patients with a Euroscore >10.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | DE/CA84/73-KL-19-07 |
| CCMO | NL18147.058.07 |