The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All-cause mortality at 30 days post-index procedure
Secondary outcome
Device Success:
Composite of absence of procedural mortality AND correct positioning of a
single prosthetic heart valve into the proper anatomical location AND intended
performance of the prosthetic heart valve (no prosthesis-patient mismatch and
mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or
severe prosthetic valve regurgitation).
Safety endpoints:
1. Composite of mortality, stroke, major vascular complication,
life-threatening bleeding, acute kidney injury (Stage 2 or 3), coronary artery
obstruction requiring intervention, and THV-related dysfunction requiring
repeat procedure at 30 days;
2. Peri-procedural mortality (<=48 hours);
3. Cardiac mortality (including any valve-related dysfunction of any
valve-related adverse event) at 30 days, 1 year, and annually thereafter;
4. Stroke at 1 year post-index procedure, and annually thereafter;
5. Major bleeding complications during procedure, at hospital discharge (or 72
hours, whichever is longer), and 30 days post-index procedure;
6. Myocardial infarction (MI) within 72 hours, 30 days, and 1 year post-index
procedure, and annually thereafter;
7. New conduction abnormality (AV block I, II, III, LBBB, RBBB, etc.) at
hospital discharge (or 72 hours, whichever is longer), 30 days, and 1 year
post-index procedure;
8. New onset atrial fibrillation at hospital discharge (or 72 hours, whichever
is longer), 30 days, and 1 year post-index procedure;
9. Time-related valve safety composite of valve structural deterioration a)
requiring repeat procedure (transcatheter or surgical heart valve replacement)
or b) evidenced by mean aortic valve gradient >=20 mmHg, EOA <=0.9-1.1 cm2*
and/or DVI<0.35, AND/OR moderate or severe prosthetic valve regurgitation,
prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic
events (e.g. stroke), and bleeding that is not clearly unrelated to valve
therapy (e.g. trauma).
Clinical efficacy endpoints:
1. Composite of all-cause mortality, all stroke, re-hospitalization for
valve-related symptoms or worsening congestive heart failure, NYHA Class III or
IV, prosthetic heart valve dysfunction (mean aortic valve gradient >=20 mmHg,
EOA <=0.9-1.1 cm2 and/or DVI<0.35, AND/OR moderate or severe prosthetic valve
regurgitation);
2. Re-hospitalization for valve-related symptoms or worsening congestive heart
failure;
3. NYHA class at 30 days, one year, and annually thereafter;
4. Six minute walk test (6MWT) at 30 days and one year;
5. Quality of Life instrument EQ5D at 30 days, one year, and annually
thereafter;
6. Length of stay for Intensive/Cardiac Care Unit, Intermediate Care Unit, and
standard ward and total index procedure.
Echocardiographic endpoints:
1. Paravalvular and total aortic regurgitation at 30 days, 1 and 5 years;
2. Indexed effective orifice area at 30 days, 1 and 5 years;
3. Mean aortic valve gradient at 30 days, 1 and 5 years;
4. Structural valve deterioration requiring repeat transcatheter or surgical
aortic valve replacement (TAVR or SAVR) at 5 years;
5. Prosthetic valve dysfunction evidenced by mean aortic valve gradient >=20
mmHg, EOA <=0.9-1.1 cm2 and/or DVI<0.35, AND/OR moderate or severe prosthetic
valve regurgitation at 30 days, 1 and 5 years;
6. LV Ejection fraction at 30 days, 1 and 5 years.
Background summary
The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use
in symptomatic patients with severe aortic stenosis requiring aortic valve
replacement (AVR) with a high surgical risk (STS Score >= 8 or EuroSCORE >= 15).
The CENTERA THV System represents the first self-expanding stent-valve model
developed by Edwards Lifesciences. The CENTERA design builds upon the
extensive clinical experience of the previous SAPIEN and SAPIENT XT valves, but
implemented in a nitinol frame.
Study objective
The purpose of this study is to assess the safety and device success of the
Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with
symptomatic, severe aortic stenosis who are indicated for aortic valve
replacement.
Study design
This is a non-randomized, prospective, multi-center safety and device success
study. One hundred fifty (150) patients are planned to be enrolled at up to 15
participating investigational centers in Europe. Patient participation will
last for a minimum of 5 years. Patients will be assessed at the following
intervals: baseline, hospital discharge, 30 days, 6 months, 1 year and annually
thereafter through 5 years. Patients will be enrolled in sequential study arms
as follows:
Initial enrollment will be limited to five sites and 50 consecutive patients.
These initial patients shall all be implanted with the CENTERA THV (23 or 26 mm
model) in their native aortic valve via the transfemoral approach.
One hundred additional patients will be enrolled at all sites with the addition
of the 29mm CENTERA THV System
Intervention
Study patients will be implanted with the CENTERA THV in their native aortic
valve via the transfemoral approach.
Study burden and risks
The burden for the patient as a result of participation in the Centera Study
can be summarized as follows:
A six-minutes walking test and the completion of Quality of Life questionnaires.
Anticipated risks have been minimized to the furthest extent possible, but the
nature of the procedure and the patient*s disease state has inherent risks.
Exposure to ionizing radiation associated with fluoroscopy, x-rays and CT is no
more than is associated with routine clinical practice for transcatheter aortic
heart valve replacement.
Complications associated with standard cardiac catheterization, balloon aortic
valvuloplasty (BAV), and the use of anesthesia may include, but are not limited
the following:
• Acute myocardial infarction
• Allergic reaction to antithrombotic therapy or contrast medium or anesthesia
• Anemia
• Aneurysm
• Angina
• Aortic valve thrombosis/occlusion
• Arrhythmias including ventricular fibrillation (VF) and ventricular
tachycardia (VT)
• Arteriovenous Fistula
• Arthralgia
• Bleeding/bruising
• Cardiogenic Shock/Pulmonary edema
• Cerebrovascular accident
• Death
• Dissection: aortic or other vessels
• Emboli, distal (air, tissue or thrombotic emboli)
• GI symptoms
• Headache
• Heart Failure
• Hematologic dyscrasia
• Hematoma
• Hemorrhage
• Hemorrhagic stroke
• Hepatic enzyme changes
• Hypotension/Hypertension
• Infection and / or pain at the access site
• Infection, fever
• Infection systemic/Sepsis
• Ischemia, myocardial
• Ischemia, limb
• Myalgia
• Perforation or Rupture of cardiac structure
• Perforation or Rupture of vessel
• Pericardial effusion/cardiac tamponade
• Peripheral nerve injury/paralysis
• Postoperative encephalopathy
• Pseudoaneurysm
• Renal Failure
• Respiratory Failure
• Shock
• Silent cerebral ischemia
• Stroke
• Syncope
• Transient Ischemic Attack (TIA)
• Vasovagal response
• Vessel Spasm
• Vessel thrombosis/occlusion
• Vessel trauma requiring surgical repair or intervention
RISKS ASSOCIATED WITH CENTERA THV AND DELIVERY SYSTEM
In addition to the risks listed in the previous section, the additional risks
listed below are specifically associated with transcatheter aortic valve
replacement and bioprosthetic heart valves. The lack of data associated with
long term CENTERA THV implants prevents predicting the incidence of these
risks. Performance of the THV placed into a failing implant (i.e., THV within
a THV) has not been evaluated. In the event of a failing implant, conversion
of traditional open surgery may be required. Additional risks include, but may
not be limited to:
• Aortic annulus dissection/rupture/trauma
• AV block
• Aortic valve insufficiency
• Injury to aortic and or mitral valve
• Acute coronary occlusion
• Allergic/immunologic reaction to the implant
• Atrial fibrillation/Atrial flutter
• Blood loss requiring blood transfusion
• Cardiac arrest
• Cognitive impairment
• Conduction disturbance including AV block requiring pacemaker
• Device malfunction requiring intervention/conversion to open heart surgery
• Endocarditis
• Hemolysis
• Mediastinitis
• Mediastinal bleeding
• Mitral regurgitation
• Peri-/Paravalvular leak/regurgitation
One Edwards Way .
Irvine 92614
US
One Edwards Way .
Irvine 92614
US
Listed location countries
Age
Inclusion criteria
1. High surgical risk: STS Score >= 8 or EuroSCORE >= 15.
2. NYHA >= II.
3. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by AVA< 1cm2 and mean gradient > 40mmHg.
4. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
5. Study patient is an adult of legal consent age.
6. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Exclusion criteria
1. Evidence of an acute myocardial infarction <= 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB >= twice normal in the presence of MB elevation and/or troponin level elevation].
2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
4. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
5. Preexisting bioprosthetic valve or ring in any position.
6. Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL), or any known blood clotting disorder.
7. Non-valvular hypertrophic cardiomyopathy with or without obstruction (HOCM).
8. Severe ventricular dysfunction with LVEF < 20%.
9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
10. Active upper GI bleeding within 1 month (30 days) prior to procedure.
11. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
12. Native aortic annulus size < 18 mm or > 27 mm as measured by CT.
13. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
14. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
15. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
16. Expectation that patient will not improve despite treatment of aortic stenosis.
17. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
18. Active bacterial endocarditis within 6 months (180 days) of procedure.
19. Access vessel characteristics that would preclude safe placement of a 16F sheath, which may include any of the following: severe obstructive calcification, severe tortuosity.
20. Known hypersensitivity to nitinol (nickel or titanium) or contrast media.
21. PCI within one month (30 days) prior to the TAVI procedure.
22. Emergency procedures within one month (30 days) prior to the TAVI procedure.
23. Severe mitral insufficiency.
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 | NCT01808274 |
| CCMO | NL43912.041.13 |