The purpose of this investigation is to evaluate the ESPOIR PV in comparison to current valve substitutes within a large prospective multicentre surveillance at 8 leading European Centres for Congenital Cardiothoracic Surgery regarding re-operation…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoints:
a. Cardiovascular adverse reactions, eg, re-operation, catheter based
interventions.
b. Serious adverse reactions, eg, infections, immunological reactions.
Primary efficacy endpoint:
Freedom from valve dysfunction leading to re-intervention or explantation at
end of the study.
Secondary outcome
Secondary safety endpoints:
a. Blood parameters as additional safety data to support presence/absence of
adverse reactions.
b. Time to reoperation, explantation and/or death.
Secondary efficacy endpoints (i.e. at end of the surveillance in comparison to
at implantation):
a. Diameter of the ESPOIR PV.
b. Transvalvular gradients.
c. Valve competence (eg, right ventricular size and function) 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 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 would have the potential to grow even when implanted in pediatric
patients.
Haverich et al. have developed a novel implant for heart valves, which is
better tolerated than the known alternatives and which has potential for
regeneration. Implants derive from donated, non-cryopreserved, homografts,
which are chemically treated to inactivate adhering microorganisms and viruses.
The heart valves then are decellularized chemically, so that only connective
tissue remains, the heart valve matrix (DHV). DHV is stable and can be stored
and shipped. It has been examined in extensive animal studies, including
immunological and toxicological analysis, which have shown that the implant is
well tolerated and recellularized by the recipient.
The DHV was approved on 22/08/2013 by the German competent authority as the
tissue preparation *ESPOIR PV* (PEI.G.11634.01.1) for pulmonary valve
replacement.
Meanwhile, more than 80 children and young adults have been treated with DHV
for pulmonary valve replacement in Chi*in*u/MD and Hannover/DE and the results
have been presented at the Annual Scientific Meeting of the American Heart
Association (AHA) in November 2010, published in September 2011 as well as
during the ESPOIR Kick-off meeting in January 2012. Although these represent
early clinical results only, none of these valves has needed to be explanted
due to degeneration or rejection, and immunological follow-up has so far
revealed no abnormalities in these patients. Moreover, a near physiological
development of valve diameters was observed.
Study objective
The purpose of this investigation is to evaluate the ESPOIR PV in comparison to
current valve substitutes within a large prospective multicentre surveillance
at 8 leading European Centres for Congenital Cardiothoracic Surgery regarding
re-operation and re-intervention rates, hemodynamic performance, growth
potential and long term durability.
Study design
This is a prospective, non-randomized, single-arm, multi-centre surveillance
study to be conducted in Europe. This study will enrol a minimum of 200
patients implanted with the ESPOIR PV. After valve 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 pulmonary valve replacement according to current medical guidelines in 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 (eg, 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 | NCT02035540 |
| CCMO | NL50870.058.14 |