Heart Valve DiseaseESPOIRNCT02035540
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
An observational study of Heart Valve Disease, run by corlife at 8 sites in 8 countries.
Trial summary
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Decellularized human valves
- How many people
- 121 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Aug 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acquired and congenital heart disease requiring heart valve replacement.
Who may be able to join
- Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
- Signed Informed consent of legal guardians or patients, assent of patients.
Who cannot join
- The patient has not provided Surveillance informed consent.
- The patient shall not suffer from
- generalized connective tissue disorders (eg, Marfan syndrome), or
- active rheumatic disorders, or
- severe asymmetric calcification of the valve ring.
- The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
- Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Italy1 site
Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP
Padova, 35128
Moldova1 site
Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU
Chisinau, 2004
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Trust, GOSH
London, WC1N 3JH
About this study
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where
- ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
- The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
- No additional diagnostic or monitoring procedures shall be applied to the patients
- and epidemiological methods shall be used for the analysis of collected data.
Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.
- Conditions
- Heart Valve Disease
- Being tested
- Decellularized human valves
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decellularized human valvesOther
Also called ESPOIR PV
| Study group | Role | What they receive |
|---|---|---|
| Decellularized human valves | Pulmonary heart valve replacement Receives: Other: Decellularized human valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of SARs (serious adverse reactions)
Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.
Measured: up to 24 months
Freedom from valve dysfunction
Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.
Measured: up to 24 months
Secondary outcomes (5)
Blood Parameters
Blood Parameters as additional safety data to support presence/absence of Adverse Reactions
Measured: up to 24 months
Diameters of ESPOIR PV at end of the study
Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation
Measured: after 24 months
Time to reoperation
Time to reoperation due to explantation
Measured: up to to 24 months
Time to death
Time to death
Measured: up to 24 months
Evaluation of transvalvular gradients
valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- corlife
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hannover Medical School, State University of Medicine and Pharmaceutics, Chisinau, Moldavia, Leiden University Medical Center, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Padova, Hôpital Necker-Enfants Malades, University of Zurich, Universitaire Ziekenhuizen KU Leuven, German Society for Tissue Transplantation, European Homograft Bank, Gottfried Wilhelm Leibniz Universität Hannover
- Responsible party
- Sponsor
- Investigators
- Axel Haverich, Prof. Dr., Principal investigator, Hannover Medical SchoolSamir Sarikouch, PD Dr., Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035540
- Sponsor's protocol ID
- Surveillance Protocol 2013-11
- Other IDs
- FP7 2007-2013, No. 278453
- Acronym
- ESPOIR
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2014
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hubler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry datadagger. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.
PubMed 30879050Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac219. doi: 10.1093/ejcts/ezac219.
PubMed 35425983
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
- ClinicalTrials.gov ID
- NCT02035540
- Acronym / sponsor ID
- ESPOIR / Surveillance Protocol 2013-11
- Conditions
- Heart Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- corlifeIndustry (pharma, biotech, devices)
- Collaborators
- Hannover Medical School, State University of Medicine and Pharmaceutics, Chisinau, Moldavia, Leiden University Medical Center, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Padova, Hôpital Necker-Enfants Malades, University of Zurich, Universitaire Ziekenhuizen KU Leuven, German Society for Tissue Transplantation, European Homograft Bank, Gottfried Wilhelm Leibniz Universität Hannover
- Study start
- Aug 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where
- ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
- The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
- No additional diagnostic or monitoring procedures shall be applied to the patients
- and epidemiological methods shall be used for the analysis of collected data.
Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decellularized human valves | – | Other: Decellularized human valvesPulmonary heart valve replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acquired and congenital heart disease requiring heart valve replacement.
Key inclusion criteria (2 listed)
- Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
- Signed Informed consent of legal guardians or patients, assent of patients.
Key exclusion criteria (7 listed)
- The patient has not provided Surveillance informed consent.
- The patient shall not suffer from
- The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
- Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decellularized human valvesAlso: ESPOIR PV | Other | Decellularized human valves |
Primary outcome
Amount of SARs (serious adverse reactions)
Time frame: up to 24 months
Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.
Freedom from valve dysfunction
Time frame: up to 24 months
Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.
5 secondary outcomes
Blood Parameters
Time frame: up to 24 months
Diameters of ESPOIR PV at end of the study
Time frame: after 24 months
Time to reoperation
Time frame: up to to 24 months
Time to death
Time frame: up to 24 months
Evaluation of transvalvular gradients
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Results publication: PubMed 30879050Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hubler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry datadagger. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.
- Results publication: PubMed 35425983Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac219. doi: 10.1093/ejcts/ezac219.
- ESPOIR WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Haverich, Prof. Dr. principal investigator
Hannover Medical School
Samir Sarikouch, PD Dr. study director
Hannover Medical School
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Disease, run by corlife at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, France, Germany, Italy, Moldova and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of SARs (serious adverse reactions) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035540, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.