The purpose of this investigation is to evaluate decellularized homograft for aortic valve replacement (ARISE AV) rates in comparison to current valve substitutes within a large prospective multicentre surveillance at 6 leading European Centres for…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoints:
1. Cardiovascular Adverse Reactions, e.g. all-cause mortality, major stroke,
life-threatening (or disabling) bleeding, acute kidney injury-stage 3
(including renal replacement therapy), peri-procedural myocardial infarction,
major vascular complication, repeat procedure for valve-related dysfunction
(surgical or interventional therapy).
2. Serious Adverse Reactions, e.g. infections, immunological reactions, etc.
Primary efficacy endpoint:
Freedom from valve dysfunction leading to re-intervention or explantation at
end of the study.
Secondary outcome
Secondary safety endpoints:
1. Blood parameters as additional safety data to support presence/absence of
adverse reactions.
2. Time to reoperation, explantation and/or death.
Secondary efficacy endpoints (i.e. at end of the study in comparison to at
implantation):
1. Diameters of the ARISE AV.
2. Transvalvular gradients.
3. Valve competence assessed by noninvasive imaging tools such as
echocardiography or cardiac magnetic resonance imaging.
Background summary
Both acquired and congenital heart disease can require heart valve replacement.
Currently available heart valve substitutes are, however, not ideal as they
require life-long anticoagulation, with the risk of bleeding when manufactured
from non-organic material, or they degenerate when derived from animals
(xenografts) or human tissue donors (homografts), leading to the need for
frequent reoperation, especially in children and young adults. An ideal heart
valve substitute is durable, does not require life-long anticoagulation and
would have the potential to grow even when implanted in pediatric patients.
Over the last decade, tissue engineering (TE) has become a promising strategy
to obtain more durable bioprosthetic valves. Allogenic matrices, established by
TE methods, have successfully been tested in large animal models and show
excellent hemodynamic results and mechanical integrity. Clinical applications,
with and without pre-seeding of autologous stem cells have been performed in
pediatric and adult patients. In recent years, implantation of non-seeded
decellularized homografts became clinical practice for pulmonary valve
replacement as spontaneous recellularization was observed by different research
groups.
The use of a decellularized homograft for the more frequently affected aortic
valve is a logical and imperative next step for this regenerative approach, but
one which harbors specific physiological challanges. Haverich.and colleagues,
after successful long term testing in large animal models, have used
decellularized allogenic heart valve matrices for aortic valve replacement on
the basis of compassionate use in 43 carefully selected patients with
auspicious initial clinical results in retrospective assessment.
Study objective
The purpose of this investigation is to evaluate decellularized homograft for
aortic valve replacement (ARISE AV) rates in comparison to current valve
substitutes within a large prospective multicentre surveillance at 6 leading
European Centres for Cardiothoracic Surgery regarding re-operation and
re-intervention, hemodynamic performance, growth potential and long-term
durability.
Study design
This is a prospective, non-randomized, single-arm, multicentre surveillance
study to be conducted in Europe. After ARISE AV implantation, patients will be
followed and assessed at discharge, 3-, 6-, 12- and, if applicable, 24- months,
thereafter.
Study burden and risks
Not applicable.
Feodor-Lynen-Straße 23
Hannover D-30625
DE
Feodor-Lynen-Straße 23
Hannover D-30625
DE
Listed location countries
Age
Inclusion criteria
1. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease.
2. Informed consent of legal guardians or patients, assent of patients.
Exclusion criteria
1. The patient has not provided surveillance informed consent.
2. The patient shall not suffer from
a. generalized connective tissue disorders (e.g. Marfan syndrome), or
b. active rheumatic disorders, or
c. severe asymmetric calcification of the valve ring.
3. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
4. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Design
Recruitment
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 | NCT02527629 |
| CCMO | NL59027.058.16 |