The objective of this study is to evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
* Overall rate of Major Serious Adverse Events (SAEs)* and serious adverse
device effects (SADE) until hospital discharge and at post-operative 30 days.
* Death, myocardial infarction, cardiac tamponade, device related cardiac
surgery, stroke
Performance
* Technical success rate of the implantation of the Cardioband
* Technical feasibility of Cardioband adjustment
* Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure,
at hospital discharge, and at 30 days.
Secondary outcome
Safety:
* Overall rate of Major Serious Adverse Events (SAEs) and serious adverse
device effects (SADE) until 12 months
Performance:
* MR Severity at 6 and 12 months
* Change in 6 MWT in 6 and 12 months
* Change in quality of life (MLHFQ) at 6 and 12 months*
Background summary
The current state of the art management of severe mitral regurgitation is
surgical mitral valve repair, either with open chest surgery or
mini-thoracotomy. However, standard surgical approaches requiring
cardiopulmonary bypass are suitable for patients with low or moderate surgical
risk; thus many patients are denied surgery because of unfavorable risk-benefit
balance. The EuroHeart Survey conducted by the ESC showed that one half of
patients with severe mitral regurgitation were denied surgical treatment
because they were felt to be at too high risk for surgery by the referring
physician. Such patients are usually elderly and have co-morbidities. Thus,
there is a need for novel devices enabling interventional cardiologists and
cardiothoracic surgeons to perform mitral annuloplasty in a transcatheter
fashion. Cardioband replicates established surgical techniques for mitral
repair (e.g., annuloplasty ring/bands), using transfermoral approach. In
addition, Cardioband is implanted without sutures and adjusted on the beating
heart. Therefore, the Cardioband System is expected to allow for treatment of
patients that would otherwise not undergo mitral valve repair due to the
invasiveness of current techniques. In addition, due to its size adjustability
capabilities under beating heart, it enables to individualize the repair and
thus may improve the outcome.
Study objective
The objective of this study is to evaluate the performance and safety of the
Cardioband Adjustable Annuloplasty System for repair of functional mitral
regurgitation.
Study design
A single arm, multi-center, prospective study with intra-subject comparisons.
This study will enrol up to 30 subjects.
Intervention
Cardioband is implanted via transseptal catheterization. Briefly: Cardioband is
fixated with anchors along the posterior mitral annulus under fluoroscopic and
Transoesophageal echocardiographic guidance. After implant deployed, implant
size adjustment is performed under echocardiographic guidance.
Study burden and risks
Every medical procedure carries risks. Since the Cardio Band an experimental
tool, some of these risks are not known. However, the doctor takes every
precaution to minimize any risks.
Those risks associated with the implantation of the CARDIO BAND - ring are
similar to those of conventional percutaneous mitral valve reconstructions.
* complications associated with anesthesia
* allergic reaction to a drug
* an inflammation of the lining of the heart ( endocarditis)
* pain
* groin bleeding
* infection
* myocardial infarction
* stroke
* blood clot
* heart failure
* abdominal pain
* cardiac arrhythmia
* fluid in the pericardium ( pericardial effusion )
* shortness of breath due to fluid in the lungs ( cardiac decompensation )
* small clots that occur on the implant itself and into your bloodstream may
end up
* anemia
* tissue damage
* perforation of the blood vessel or portion of the heart
* failure of the medical device - a surgery may be required to explant the
device
* death
As with other mitral rings , the Cardio Band ring can over time become impaired
under the influence of chemicals present in the body ( corrosion ) or due to
physical stress ( eg high blood pressure ) . As a result, a new surgical
intervention, if any, must be done to remove the ring.
(*) At each participating site, a cardiac surgeon is being trained on
Cardioband implant removal. The decision will be made upon the physician
discretion. The Cardioband does not prevent any future treatment, in the
unwanted case of failure the patients can stay under a clinical follow up,
undergo Mitraclip procedure or be referred to surgery.
Important information for women
Women who are pregnant or breastfeeding cannot take part in this study .
Radiation
The length of time and exposure to radiation during the implant will be
minimized. The amount of radiation is about the same as for those patients that
would be treated with a MitraClip.
Benefits
Potential benefits for patients in whom the device is implanted, include the
following:
* less tired or weak
* less chest pain
* in contrast to other rings, the CARDIO BAND-ring is inserted by means of a
transfemoral surgery. That means it is inserted through the femoral vein. For
the implantation of the valve, the chest does not need to be opened. This may
shorten the healing time and hence the time the patient is in hospital after
surgery.
* CARDIO BAND ring is implanted while the heart is beating. During
implantation, the physician has the ability to adapt the CARDIO BAND ring to
the size of your heart valve. The expectation is that this increases the
clinical benefits and new operations are not necessary because of residual
leakage of the valve.
* Currently there is one method for the treatment of leaking mitral valve in
patients for whom open heart surgery entails a high risk available, namely the
mitral clip. If a patient does not qualify for a MitraClip, treatment with
medication would be the only remaining option; Thus, for those patients
enrolled in this study, treatment by means of the cardio-band can be considered
a benefit.
This research may also mean an improvement for the future treatment of heart
failure.
Ariel Sharon Ave. 3
Or Yehuda 60376
IL
Ariel Sharon Ave. 3
Or Yehuda 60376
IL
Listed location countries
Age
Inclusion criteria
* Age > 18 years
* Moderate to severe functional MR
* Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including CRT if indicated.
* LVEF * 25%, LVEDD * 70mm
* Subject is high risk to undergo MV surgery (as assessed by a cardiac surgeon and a cardiologist at the site, and according to ESC/EACTS guidelines on the management of valvular heart disease)
* Transseptal catheterization and femoral vein access is determined to be feasible
* Subject is able and willing to give informed consent and follow protocol procedures
Exclusion criteria
* Active bacterial endocarditis
* Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
* Heavily calcified annulus or leaflets
* Subjects in whom transesophageal echocardiography is contraindicated
* Untreated clinically significant CAD requiring revascularization
* Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
* CVA or TIA within 6 months or severe carotid stenosis (>70% by Ultra sound)
* Renal insufficiency requiring dialysis
* Life expectancy of less than twelve months
* Patient is pregnant (urine HCG test result positive) or lactating
* Known sensitivity or allergy to Nickel or Chromium
* Known sensitivity or contraindication to procedural medications which cannot be adequately managed medically
* Bleeding or clotting disorders
* Subject is participating in concomitant research studies of investigational products
* Pulmonary hypertension >70mmHg at rest
* Mitral valve anatomy which may preclude proper device treatment
* Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation
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 |
|---|---|
| ClinicalTrials.gov | NCT01841554 |
| CCMO | NL46113.100.14 |