For Patients

WHAT IS THE PURPOSE OF THE STUDY? 

The purpose of this investigation is to evaluate decellularized human heart valves (DHV) for pulmonary valve replacement. 

WHO CAN TAKE PART?

The Study will be performed as an observational, a so called non-interventional trial.  As a result of discussion with your attending physician the decision for surgical pulmonary valve replacement with a decellularized human heart valve has to be made in advance.  Patients may be then asked to participate in this Study.  Participation in the Study is completely voluntary and it is up to the patients to decide whether or not they wish to take part or to discontinue their participation. The decision for receiving a pulmonary valve replacement with DHV is clearly separated from the decision to participate in the Study.  

WHAT IS INVOLVED IN THE STUDY?

The valve replacement is performed via a standardized operation for pulmonary valve replacement using cardio-pulmonary-bypass (heart-lung-machine) as with any other pulmonary valve substitute. In our follow-up examinations, we focus on heart valve function during non-invasive examinations like ultrasound check-up (echocardiography) and cardiac magnetic resonance (CMR). All clinical examinations, both before and after the implantation, will be carried out in routine care that all patients with congenital heart disease requiring pulmonary valve replacement receive. The Study is about to systematically collect and analyze these data. 

WHAT ARE THE RISKS OF TAKING PART IN THIS STUDY?

Your doctor will make every effort to minimize the risks and discomforts of the procedure of heart valve replacement. Most risks and complications can be effectively treated with medications or surgery that can be provided to you at your doctor’s decision.  Some complications could result in serious injury or death despite additional treatment.  In the event of a serious complication or injury, it may be necessary to surgically remove the valve.  As the procedures in this Study do not go beyond the standard care, there are no additional medical risks attached to the Study. The persons involved will make any reasonable effort to maintain the privacy of patient data. 

ARE THERE ANY BENEFITS OF TAKING PART IN THIS STUDY?

Patients may not directly benefit from participating in this Study but may contribute to new information for the benefit of recent and future patients. Patients will receive no payment or other recompense for participating in the Study. The Study is supported by the European Commission. The participating centers nor the physicians receive any additional incentives.  No additional costs will arise for patients or their health insurance company as a result of participation in this study.

HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?

The clinical study of ESPOIR is conducted at 8 centres in Europe including a total of 200 patients, children and adults, with congenital heart defects.  At each hospital, 25 patients will take part in the Study.

QUESTIONS ABOUT RESEARCH 

If you have any questions about the Study you should contact the Department of Cardiac, Thoracic, Transplantation and Vascular Surgery at Hannover Medical School (Director: Prof. Dr. Dr. A. Haverich). If you have questions about your ethical issues, you may contact the ESPOIR Ethics and Governance Council (www.espoir-egc.eu).