To further study the safety and effectiveness of the MitraClip system in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class III or Class IV chronic heart…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hierarchical composite of all-cause mortality and recurrent heart failure
hospitalizations..
Secondary outcome
• Composite of all-cause mortality, stroke, myocardial infarction, new need for
renal replacement therapy and non-elective cardiovascular surgery for device
related complications in the Device group at 30 days
• Mitral Regurgitation (MR) severity of mild or mild-to-moderate at 12 months
• Change in Left Ventricular End Diastolic Volume (LVEDV) at 12 months over
baseline
• Change in Left Ventricular End Systolic Volume (LVESV) at 12 months over
baseline
• Change in 6 Minute Walk Test (6MWT) distance at 12 months over baseline
• Change in Quality of Life (QoL) score, as measured by Kansas City
Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline
• New York Heart Association (NYHA) Functional Class I/II at 12 months over
baseline
In addition also Health Economic Endpoints:
• Device procedure cost including device and associated equipment, operative
time, staff time and length of hospital stay (Intensive Care Unit (ICU) and
non-ICU)
• All-cause re-hospitalizations (time to each hospitalization and length of
each hospitalization) at 12 months and 24 months
• Concomitant cardiac treatments (medications and invasive/semi-invasive
procedures)
• Discharge location after each hospitalization (e.g., home, home with home
health care, skilled nursing, long-term acute care)
• Inpatient and outpatient physician visits (related to MR and heart failure
excluding scheduled trial-related follow-up visits)
• Management of device-related adverse events
Background summary
The trial is designed to provide additional evidence concerning the appropriate
recommendations for the use of the MitraClip system in the treatment of chronic
heart failure patients with significant functional mitral regurgitation (MR).
Additionally, the trial will collect evidence regarding health economics of the
MitrClip system for use in this patient population.
Study objective
To further study the safety and effectiveness of the MitraClip system in the
treatment of clinically significant functional mitral regurgitation in patients
with New York Heart Association (NYHA) Functional Class III or Class IV chronic
heart failure.
Study design
Prospective, randomized, parallel-controlled, multi-center clinical evaluation
of the MitraClip device plus optimal standard of care therapy (Device group)
compared to optimal standard of care therapy alone (Control group).
Eligible subjects will be randomized in a 1:1 ratio to the Device group or
Control group.
Intervention
The Device group will recieve the optimal standard of care therapy and the
MitraClip placement.
The Control group will only receive the optimal standard of care therapy ( by
ESC guidelines for heart failure).
All the subject must remain in their randomized group for a minimum of 12
months. Subjects in the control group will be allowed to undergo the mitraclip
procedure only after the subject has completed 24months follow up visit or the
last randomized subject has completed a 12MFU visit , whichever occurs earlier.
Study burden and risks
Heart failure patients with clinically significant functional MR have limited
options for the treatment of their valvular insufficiency. Current options to
treat their FMR include medical management and occasionally mitral valve repair
or replacement surgery.
Medical management of heart failure patients with FMR is intended to reduce
symptoms and improve quality of life; yet medical management does not treat the
mechanical malcoaptation of the mitral valve leaflets, and therefore is not a
long-term treatment solution for their MR. Ongoing MR in medically managed
patients eventually leads to deterioration in cardiovascular function and thus,
worsening heart failure. The prognosis is poor for heart failure patients with
FMR who are primarily on medical therapy, as the main cause of the heart
failure is not effectively addressed by available medical therapy.
In this clinical trial, the overall risk versus benefit analysis of the
MitraClip System is based on weighing the potential risks and benefits of the
MitraClip System combined with optimal medical therapy against the known risks
and benefits associated with optimal medical therapy alone.
The risks associated with the MitraClip procedure can be grouped into two
categories. First, there are potential risks associated with standard cardiac
catheterization, including transseptal catheterization, the transesophageal
echocardiogram (TEE) probe and the potential risks of general anesthesia.
Second, there are the potential risks uniquely associated with the use of the
MitraClip System.
For details, please refer to Clinical Investigation Plan 12-513: Version 2.0 dd
2Oct2012 page 81-83
Park Lane culliganlaan 2B
Diegem 1831
BE
Park Lane culliganlaan 2B
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
- Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR),
as defined by European Association of Echocardiography, within 90 days prior to
randomization and confirmed by the echocardiograpphy corelab.
- Age between 18 years and 90 years old
- Assessed by the investigator to be on optimal standard of care therapy for heart failure,
as described in Section 5.7 Baseline Treatment Optimization, for at least 4 weeks
with no dose changes of heart failure drugs (with the exception of diuretics) during the
last 2 weeks immediately prior to randomization.
- Documented New York Heart Association Class III or Class IV heart failure, despite
optimal standard of care therapy 50, within 90 days preceding randomization. Therapy 50 means optimal medical and/or device therapy includes optimal stabilization of symptoms with the use of appropriate evidence based therapies including medicines, revascularization and cardiac resynchronization therapy with or without cardioverter defibrillator as indicated per ESC guidelines( see for more explanation "aanvullende opmerkingen"..)
- Minimum of one documented hospitalization (acute care admission or emergency room
visit) for heart failure within 12 months preceding randomization OR values of at least
350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical
and/or device management within 90 days preceding randomization
- Left ventricular ejection fraction (LVEF) >= 15% and <= 40% determined by
echocardiography within 90 days prior to randomization and confirmed by the ECL
- LVEDD >=55mm determined by TTE within 90 days prior to randomization and confirmed by the ECL
Exclusion criteria
For all Excl criteria see page 36-38 of CIP 2.0
- Mitral regurgitation is primarily due to degenerative disease of the mitral valve
apparatus (Degenerative MR), as determined by TEE.
- Status 1 heart transplant or prior orthotopic heart transplantation
- Introduction of a new heart failure drug class within the last 4 weeks prior to
randomization
- Any cardiovascular hospitalization within the last 2 weeks immediately prior to
randomization.
- Evidence of acute coronary syndrome, TIA or Stroke within 90 days prior to randomization.
- Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery
or atrial fibrillation ablation within 90 days prior to randomization
- Mitral valve surgery is considered a therapeutic option for the subject
- Renal replacement therapy
- 6MWT distance > 450 meters
- Contraindication to transseptal catheterization
- subjects in whom TEE is contraindicated
- Active infections requiring current antibiotic therapy
- Severe right ventricular failure or 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 |
|---|---|
| Other | http://www.clinicaltrials.gov |
| CCMO | NL41064.100.12 |