European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

Completed

• Conditions: Heart Valve Disease

• 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

Study Timeline

• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Study Start: 2014-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
• Signed Informed consent of legal guardians or patients, assent of patients.

Exclusion Criteria

• 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

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
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
Time to reoperation	up to to 24 months	Time to reoperation due to explantation
Time to death	up to 24 months	Time to death
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

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

Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU; 🇲🇩 Chisinau, Moldova, Republic of

Leids Universitair Medisch Centrum, LUMC; 🇳🇱 Leiden, Netherlands

Universitaet Zuerich, UZH, Switzerland; 🇨🇭 Zuerich, Switzerland

Great Ormond Street Hospital for Children NHS Trust, GOSH; 🇬🇧 London, United Kingdom