To evaluate and compare complication and mortality rates tocurrent rates available for repairs with commercially availableannuloplasty rings. (0, 0+)
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the occurrence of; death, endocarditis,
ring dehiscence, systolic anterior motion (SAM), embolic event,
pulmonary edema, heart block, arrhythmia, hemolysis, and myocardial
infarction (MI) at 30 days post-procedure.
The primary efficacy endpoint is ability to reduce mitral regurgitation to
less than 2+ immediately following surgical implantation of the
annuloplasty device.
Secondary outcome
The secondary safety endpoint is the occurrence of; death, endocarditis,
ring dehiscence, systolic anterior motion (SAM), embolic event,
pulmonary edema, heart block, arrhythmia, hemolysis, and myocardial
infarction (MI) at 6 months post-procedure.
The secondary efficacy endpoint is the ability to further reduce residual
regurgitation following annuloplasty ring implantation and /or to enhance
coaptation distance using intra-operative activation of the device.
Background summary
Surgically placed annuloplasty ring for the treatment of mitral
regurgitation (MR) with an intra-operative shape change option for
additional optimization.
To assess the safety and efficacy of the MiCardia Dynamic Annuloplasty
System for the treatment of mitral regurgitation with optional intraoperative
activation and optimization.
The Dyana ring will be used for the first time in humans.
Study objective
To evaluate and compare complication and mortality rates to
current rates available for repairs with commercially available
annuloplasty rings. (0, 0+)
Study design
Single arm, multi-center, prospective study
Intervention
Surgically placed annuloplasty Nitinol ring for the treatment of mitral
regurgitation (MR) with an intra-operative shape change option for
additional optimization.
Shape change will be achieved by RF energy.
Study burden and risks
ADDITIONAL RISK WITH THE USE OF INTRA-OPERATIVE ACTIVATION
Risks of the Intra-Operative Wire Placement
· Perforation/tamponade
· Pericardial Effusion
· System damage
Risks of the Intra-Operative Wire Activation
· Possibility of Heart arrhythmia
· Possibility of tissue damage with the RF energy
· Thrombosis
· Risk of bleeding of left atrial incision
· Ring damage
· Ring dehiscence
Risks of the Reshaped Dynamic Annuloplasty Ring
· Possibility of worsening MR
· Possibility of tissue damage due to tension
· Possibility of suture stitch damage
Benefits
The use of The MiCardia Dynamic Annuloplasty Ring System allows for
conventional surgical
mitral valve repair with the optional feature of off-pump real-time ring shape
adjustment. The
direct benefit to the patient is the ability of the surgeon to review the
echocardiographic data post
surgical implant and allow for ring shape changes to reduce any residual MR
that may be present
and/or to optimize leaflet coaptation. Both adjustment options are to improve
the initial surgical
outcome, which is expected to minimize the likelihood of a second, invasive
by-pass surgery.
30 Hughes, Suite 206,
Irvine, CA USA 92618
US
30 Hughes, Suite 206,
Irvine, CA USA 92618
US
Listed location countries
Age
Inclusion criteria
1.This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
2.This patient has been diagnosed with a diseased natural valve, based on
echocardiography and is a candidate for mitral valve repair.
3.This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively)
Exclusion criteria
1. This patient is less than eighteen (18) years of age.
2. This patient has a non-cardiac major or progressive disease, which in the investigators experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
3. Patient who has heavily calcified annulus or leaflets.
4. reoperation
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 |
|---|---|
| CCMO | NL26230.078.09 |