Primary Objective:To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to published data with a conventional valve within a MIS approachSecondary Objectives:To describe short term (30 days) and long term (6 months) clinical safetyTo…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aortic Cross Clamp time
Secondary outcome
Secondary endpoints:
Cardiopulmonary bypass time
Procedure time
Valve implant time
Device technical success (defined as the successful delivery and deployment of
a study valve and delivery system and subject leaving the operating room with
valve in place)
First Attempt Success Rate
ICU and Hospital Length of Stay
Hemodynamic performance (mean gradient, peak gradient, effective orifice area
[EOA], EOA index, performance index, cardiac output [CO], cardiac index [CI],
valvular regurgitation [including paravalvular leak]) confirmed by an
Echocardiographic Core Laboratory at Discharge and 6 months (if available)
Patient related endpoints:
NYHA functional class compared to baseline
Change in Quality of Life questionnaire Form 36 (SF-36) and EQ-5D from
Screening to 6 months
Fitness for hospital Discharge
Safety endpoints:
Complication rates at 30 days (early rates) and at 6 months :
All cause mortality
o Study valve-related mortality
Thromboembolism
o Stroke
o TIA
o Non cerebral embolism
Valve Thrombosis
Major Bleeding event
Endocarditis (study valve)
Structural valve deterioration
Non Structural valve deterioration
o Paravalvular Leak minor
o Paravalvular Leak major
o Other non SVD
Reoperation
o Trial valve reoperation
Hemolysis
Study valve explants
Implant-related new or worsened cardiac conduction disturbance requiring
permanent pacemaker implant
Renal Failure
Respiratory dysfunction
Deep Sternal Wound infection
The Clinical Events Committee (CEC) will evaluate the
adverse events including adverse events resulting in death as outlined in their
charter and adjudicate these events for their relatedness to the
investigational device, and the investigational device procedure.
Background summary
The EDWARDS INTUITY Elite System has been designed to facilitate minimally
invasive surgery (MIS) introduction of the bioprosthetic valve.
This active, open-label, non-randomized, post-market study will describe in a
real world cohort, procedural, clinical and hemodynamic outcomes of Minimally
Invasive Surgery (MIS) for isolated Aortic valve Replacement (AVR) in the
context of EDWARDS INTUITY Elite Valve System.
Patient assessments will be done according to standard of care.
The primary hypothesis of the study is that EDWARDS INTUITY Elite reduces cross
clamp time (XCT) in MIS setting when compared to published data with a
conventional valve in the same setting.
Study objective
Primary Objective:
To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to
published data with a conventional valve within a MIS approach
Secondary Objectives:
To describe short term (30 days) and long term (6 months) clinical safety
To assess and compare hemodynamic data with EDWARDS INTUITY Elite to a
conventional valve at discharge and at 6 months post AVR
To assess Quality of Life at baseline, and at 6 months post AVR
To assess NYHA functional class at baseline, discharge, 1 month and at 6 months
post AVR
To assess Fitness for hospital discharge
Study design
This multi-center registry is open-label, prospective, single arm and
non-randomized.
Baseline characteristics of subjects shall be collected. Risk scores (Euroscore
I and II) will be collected by registry sites.
Intra-operative data including cross-clamp time (XCT), bypass times, procedure
times and first implant success will be recorded. The intensive care unit
(ICU), total hospital durations and fitness to hospital discharge will be
recorded. All adverse events will be recorded.
Early postoperative (* 30 days) safety data will be collected to evaluate short
term outcomes.
Quality of Life will be collected at baseline and 6 months (EQ-5D and SF-36).
Follow-up data will be collected and evaluated at 6 months.
Patient assessments will be done according to standard of care.
Study burden and risks
Patients need to fill in two questionnaires preoperatively. This will take
approximately 15 minutes. These questionnaires will be repeated after 6 months.
This will also take approximately 15 minutes. Also, a phonecall shall be made
30 days after surgery. This will take 5 minutes. Six months after surgery an
ultrasound of the heart will be made and the questionnaires will be filled in
again. Also, blood tests will be done at that time. This will take
approximately one hour. In total the burden for the patients shall amount to
approximately 2 hours (not including time needed for traveling to the
hospital).
The risks associated with participation in this trial regarding the minimally
invasive procedure are comparable with the risks associated with the
conventional treatment.
Route de l'Etraz 70
Nyon 1260
CH
Route de l'Etraz 70
Nyon 1260
CH
Listed location countries
Age
Inclusion criteria
1. Subject is 18 years or older
2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
4. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
5. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion criteria
1. Subject is diagnosed with pure aortic insufficiency.
2. Subject requires multiple valve replacement/repair
3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
4. Subject has severe ventricular dysfunction defined as LVEF < 25%.
5. Subject has a history of active endocarditis and/or myocarditis * 3 months before the intended treatment/scheduled surgery.
6. Subject has had an acute MI * 3 months before the intended treatment.
7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
8. Subject is oxygen or ventilator dependent.
9. Subject has life expectancy < 12 months.
10. Female subject is pregnant or lactating.
11. Subject with documented leukopenia (WBC < 3.5x 103/*L), acute anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.
12. Subject has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 1 month of procedure.
13. Subject has documented echocardiographic evidence of intracardiac mass, thrombus or vegetation.
14. Subject has renal insufficiency as determined by Serum creatinine * 200 *mol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
15. Subject with documented hyperparathyroidism.
16. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
17. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
18. Aneurysm of the aortic root and/or ascending aorta;Intra-operative exclusion criteria:
1. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)
2. Subject has calcium on the anterior mitral leaflet which cannot be removed.
3. Subject has extensive calcification of the aortic root.
4. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
5. The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
6. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).
7. The device is not available in the correct size for the subject.
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 | NL57530.100.16 |