The objective of the study is to demonstrate the safety, feasibility and potential efficacy of using GDS Accucinch System in human subjects with heart failure and clinically significant functional mitral regurgitation.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Safety through 30 days assessed by the rate and severity of major
adverse cardiac and cardiovascular events (MACCE) and device and procedure
related major adverse events (MAE).
Secondary outcome
Efficacy will be assessed by one or more of the following measures:
• Reduction in MR acutely, and at 30 days and
6M follow-up, as measured by echocardiography
• Evidence of left ventricular reverse remodeling during follow-up, as measured
by echocardiography
Symptom improvement (NYHA Class, 6-minute walk test, and/or QoL)
Feasibility: Ability to establish access to the mitral
subannular groove, to deploy the anchors, to reshape the mitral
apparatus, to deploy the lock,
and to cut the cinching cable.
Safety: MAE through 6 months.
Background summary
Mitral valve regurgiation (MR)is an abnormal reflow of the blood from the left
ventricle to the left atrium during heart beat. MR causes an extra load to the
heart during beating due to the need of the left chamber to pump more blood per
beat to ensure sufficient blood flow the rest of the body.
By functional MR are the leaflets of the mitral valve healthy and not the cause
of the insufficiency, but is the regurgitation usually caused by and enlarged
heart which is caused by previous damage to the heart for instance from a heart
attack or by a disorder of the heart muscle. The muscles around the mitral vlve
can be enlarged or streched causing a disfunction of tthe little muscles
regulating the opening and closing of the leaflets resulting in regurgiation of
the blood flow.
There are limited treatment options for this medical condition. Although
medical therapy improves the symptomes of the condition, it is not proven that
the survival is increased. The mitral valve can be surgically repaired or
replaced, but this is a very invasive treatment with risks related to heart
surgery.
The accucinch system is intended to reshape the geometry of the mitral
apparatus to reduce functional mitral valve regurgitation using standard
percutaneous interventional cardiology techniques. A cinch cable is attached by
means of anchors in the subannular groove of the mitral valve in order to
reduce MR.
Study objective
The objective of the study is to demonstrate the safety, feasibility and
potential efficacy of using GDS Accucinch System in human subjects with heart
failure and clinically significant functional mitral regurgitation.
Study design
This clinical trial is a prospective, single-arm study that will be conducted
at up to 25 investigational sites in Canada and other countries.
The patients will undergo an extensive screening in cooperation with the
sponsor of the project after which the accucinch system will be implanted. The
patients will have follow-up at 1,3, 6 en 12 months post-procedure.
A study flow chart is described in the protocol on page 13.
Intervention
The procedure to implant the Accucinch System involves obtaining vascular
access from the femoral artery, advancing catheters into the heart retrograde
crossing the aortic valve and gaining access to the mitral subannular groove.
Positioning into the mitral subannular groove is established with a specialized
Guide catheter that directs subsequent devices into the space. A guide wire is
advanced through the Guide catheter and circumnavigates the groove. Once the
guide wire is placed, a specialized sheath is advanced over the wire and into
the groove. This provides guidance and support for specialized Delivery
Catheters directed towards the myocardium to deploy a series of anchors into
the posterior wall of the left ventricle, approximating the mitral valve
commissure-commissure arc. Any anchors that have been identified as unsecured
to the myocardium after being deployed will be retrieved using the Anchor
Retrieval Catheter. The anchors are slidably-connected via a high-strength
Cinching Cable. The Cinching Cable is anchored to the primary (distal) Anchor,
and passes through eyelets of the secondary Anchors. Following deployment of
the last Anchor, tension is applied to the Cinching Cable, which draws the
anchors closer to each other, thus, reducing the circumferential and
septal-lateral dimensions of the mitral apparatus. This, in turn, is
anticipated to result in reduced mitral regurgitation. A Lock is then secured
to the Cinching Cable to maintain tension. Finally, excess Cinching Cable is
cut close to the lock by a cutting tool inserted through the Guide catheter.
Study burden and risks
The GDS Accucinch® System procedure was developed as an alternative to the use
of rigid or semi-rigid annuloplasty rings and complex valve repair techniques
in arrested heart surgery. Typical valve repair or replacement surgery exposes
patients to a number of risks, including those associated with: general
anesthesia, cardiopulmonary bypass, sternotomy or thoracotomy and long term
anticoagulation required for some replacement heart valves. In addition, there
is the risk of failure of the valve repair or replacement procedure which may
require reoperation. The risks associated with reoperation are greater than
for the initial surgical repair or replacement procedure.
The additional burden to the patients are the follow-up visits at 1, 3, 6 and
12 months post-procedure including anamnesis, ECG, questionnaire, 6-minute
walking test, echocardiogaphy and the reporting of medication and adverse
events.
Calle de Luna 2355
Santa Clara CA 95054
US
Calle de Luna 2355
Santa Clara CA 95054
US
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years
2. Subjects with clinically significant mitral regurgitation (MR 2+ and above)
3. Ejection Fraction >= 25%
4. Stable cardiac medical regimen for heart failure for at least 1 month
5. Stable NYHA Classification for at least 1 month
6. Subject is eligible for cardiac surgery
7. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent
Exclusion criteria
1. Myocardial infarction within 90 days of the intended treatment with the device
2. Prior surgical, transcatheter, or percutaneous mitral valve intervention
3. Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease.
4. Hemodynamic instability or the need for emergent surgery
5. Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
6. Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
7. Echocardiography evidence of primary mitral valve disease causing MR or MS
8. Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm²
9. Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
10. Estimated GFR of <30ml/min/1.73m²
11. Greater than mild mitral annular calcification observed by fluoroscopy
12. Presence of aortic valve prosthesis
13. Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
14. Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
15. Active bacterial endocarditis
16. History of bleeding diathesis or coagulopathy
17. History of stroke within the prior 6 months
18. Subjects in whom anticoagulation is contraindicated
19. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
20. Concurrent medical condition with a life expectancy of less than 12 months
21. Currently participating in an investigational study
22. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
23. Subjects with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair
24. Any cardiac resynchronization therapy within the last 3 months prior to treatment
25. Subjects on high dose steroids or immunosuppressant therapy
26. Female subjects who are pregnant, of child bearing potential or lactating
27. Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
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 | NL38146.100.11 |