European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
- Conditions
- Heart Valve Disease
- Interventions
- Other: Decellularized human valves
- Registration Number
- NCT02035540
- Lead Sponsor
- corlife
- Brief 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.
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
- Signed Informed consent of legal guardians or patients, assent of patients.
-
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®.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Decellularized human valves Decellularized human valves Pulmonary heart valve replacement
- Primary Outcome Measures
Name Time Method Amount of SARs (serious adverse reactions) up to 24 months Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.
Freedom from valve dysfunction up to 24 months Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.
- Secondary Outcome Measures
Name Time Method Time to death up to 24 months Time to death
Blood Parameters up to 24 months Blood Parameters as additional safety data to support presence/absence of Adverse Reactions
Evaluation of transvalvular gradients up to 24 months valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging
Diameters of ESPOIR PV at end of the study after 24 months Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation
Time to reoperation up to to 24 months Time to reoperation due to explantation
Trial Locations
- Locations (8)
Universitair Ziekenhuis Leuven, UZL
🇧🇪Leuven, Belgium
Université Paris Descartes, UPD
🇫🇷Paris, France
Hannover Medical School
🇩🇪Hannover, Germany
Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP
🇮🇹Padova, Italy
Leids Universitair Medisch Centrum, LUMC
🇳🇱Leiden, Netherlands
Great Ormond Street Hospital for Children NHS Trust, GOSH
🇬🇧London, United Kingdom
Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU
🇲🇩Chisinau, Moldova, Republic of
Universitaet Zuerich, UZH, Switzerland
🇨🇭Zuerich, Switzerland