To evaluate the safety and effectiveness of the Model 400 Aortic Valve Bioprosthesis. LTFU:To evaluate the long-term safety and effectiveness of the Avalus Bioprosthesis.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Safety:
a. Thromboembolism
b. Valve Thrombosis
c. Hemorrhage
d. Paravalvular leak
e. Endocarditis
f. Hemolysis
g. Structural valve deterioration
h. Non-structural dysfunction
i. Reintervention
j. Explant
k. Death
2. Effectiveness:
a. Hemodynamic Performance Metrics
b. New York Heart Association Functional Classification
Secondary outcome
N/A
Background summary
Medtronic, has developed a new heart valve, called Model 400 made of bovine
(cow) tissue. Bovine pericardial aortic heart valves have good left ventricular
mass regression (remodeling), freedom from structural valve deterioration
(SVD), and a high rate of survival, which may offer better early hemodynamics
(low transvalvular pressure gradients and increased effective orifice area) and
ease of use (low stent profiles). For these reasons, bovine pericardial heart
valves hold the majority of the stented aortic heart valve market. Therefor
Medtronic developed this valve.
De PERIGON LTFU is a longitudinal investigational clinical trial with long-term
follow-up of subjects who are enrolled in the PERIGON Pivotal Trial, who
received the Avalus valve, and who consent to participate in long-term follow
up. The subjects will be followed up to 12 years post-implant.
Study objective
To evaluate the safety and effectiveness of the Model 400 Aortic Valve
Bioprosthesis.
LTFU:
To evaluate the long-term safety and effectiveness of the Avalus Bioprosthesis.
Study design
This is a prospective, interventional, non-randomized, worldwide, multi-center
trial.
Intervention
aortic valve replacement via open-heart surgery
Study burden and risks
Study Procedures:
After the implantation there will be six follow up visits planned. These visits
need to be performed in the hospital who implanted the valve. During these
follow up visits the perfomance of the Model 400 will be checked via echo.
Additionaly there will be an ECG made, bloodsamples will be taken and they will
inform to the current health and the medication.
Besides the yearly follow up visits the patient will be contacted by phone 1.5
and 2.5 year after the valve implantation. Also during these phone call follow
ups the patient will be asked for current health and the use of medication.
LTFU:
Subjects will undergo evaluation annually from 6 years through 12 years (±60
days) post-procedure.
Evaluations will be performed either in-person at the study center (years 7,
10, and 12) or via telephone
call (years 6, 8, 9, and 11). The following evaluations will be completed, and
data collected on the
electronic case report forms (eCRFs):
• NYHA classification (may be performed via phone in years 6, 8, 9, and 11 per
institutional standard
practice)
• 12-Lead electrocardiogram (ECG) (only required at years 7, 10, and 12)
• Transthoracic echocardiography (TTE) (only required at years 7, 10, and 12)
• Safety endpoint events
• All reportable Adverse Events and Device Deficiencies
• Relevant medications
• Vital status
Risks:
Every surgery contains risks. General surgical risks include problems from the
anesthesia, side effects from the medication used, bleeding at the operation
site, heart attack and infections.
The main risk with the Model 400 aortic valve bioprosthesis is like the risk of
approved heart valves. This means that the artificial heart valve may have or
cause a problem at some time after the operation.
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
1. Patient has moderate or greater aortic stenosis or regurgitation, and there
is clinical indication for replacement of their native or prosthetic aortic
valve with a bioprosthesis, with or without concomitant procedures, which are
limited to any of the following:
i. LAA ligation
ii. CABG
iii. PFO closure
iv. Ascending aortic aneurysm or dissection repair not requiring circulatory
arrest
v. Resection of a sub-aortic membrane not requiring myectomy
2. Patient is geographically stable and willing to return to the implanting
site for all follow-up visits
3. Patient is of legal age to provide informed consent in the country where
they enroll in the trial
4. Patient has been adequately informed of risks and requirements of the trial
and is willing and able to provide informed consent for participation in the
clinical trial
LTFU:
1. Subject is a participant in the PERIGON Pivotal Trial and is implanted with
the Avalus valve;
2. Patient is of legal age to provide informed consent in the country where
they enroll in the trial;
3. Patient has been adequately informed of risks and requirements of the trial
and is willing and able to provide informed consent for participation in the
clinical trial;
4. Patients must be geographically stable and willing to return to the
implanting site for all follow-up visits.
Exclusion criteria
1. Patient has a pre-existing prosthetic valve or annuloplasty device in
another position or requires replacement or repair of the mitral, pulmonary or
tricuspid valve 2. Patient has had previous implant and then explant of the
Model 400 aortic valve bioprosthesis 3. Patient presents with active
endocarditis, active myocarditis or other systemic infection 4. Patient has an
anatomical abnormality which would increase surgical risk of morbidity or
mortality, including: • Ascending aortic aneurysm or dissection repair
requiring circulatory arrest • Acute Type A aortic dissection • Ventricular
aneurysm • Porcelain aorta • Hostile mediastinum • Hypertrophic obstructive
cardiomyopathy (HOCM) • Documented pulmonary hypertension (systolic >60mmHg)
5. Patient has a non-cardiac major or progressive disease, with a life
expectancy of less than 2 years. These conditions include, but are not limited
to: • Child-Pugh Class C liver disease • Terminal cancer • End-stage lung
disease 6. Patient has renal failure, defined as dialysis therapy or GFR<30
mL/min/1.73 m2 7. Patient has hyperparathyroidism 8. Patient is participating
in another investigational device or drug trial or observational competitive
study 9. Patient is pregnant, lactating or planning to become pregnant during
the trial period 10. Patient has a documented history of substance (drug or
alcohol) abuse 11. Patient has greater than mild mitral valve regurgitation or
greater than mild tricuspid valve regurgitation as assessed by echocardiography
12. Patient has systolic EF<20% as assessed by echocardiography 13. Patient
has Grade IV Diastolic Dysfunction 14. Patient has documented bleeding
diatheses 15. Patient has had an acute preoperative neurological deficit or
myocardial infarction and has not returned to baseline or stabilized >=30 days
prior to enrollment 16. Patient requires emergency surgery LTFU: 1. Subjects
who have had an explant of the Avalus valve prior to the long-term follow up
study period; 2. Subjects who have had a valve in valve prior to the long-term
follow up study period; 3. Subject unable or unwilling to return for study
follow-up visits.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NCT02088554 |
| CCMO | NL45419.058.13 |