European Clinical Study for the Application of Regenerative Heart Valves

Recruiting

Conditions: Pulmonary valve disease
10046973

Registration Number: NL-OMON40749

Lead Sponsor: corlife oHG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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®.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary safety endpoints:<br /><br>a. Cardiovascular adverse reactions, eg, re-operation, catheter based<br /><br>interventions.<br /><br>b. Serious adverse reactions, eg, infections, immunological reactions.<br /><br><br /><br>Primary efficacy endpoint:<br /><br>Freedom from valve dysfunction leading to re-intervention or explantation at<br /><br>end of the study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary safety endpoints:<br /><br>a. Blood parameters as additional safety data to support presence/absence of<br /><br>adverse reactions.<br /><br>b. Time to reoperation, explantation and/or death.<br /><br><br /><br>Secondary efficacy endpoints (i.e. at end of the surveillance in comparison to<br /><br>at implantation):<br /><br>a. Diameter of the ESPOIR PV.<br /><br>b. Transvalvular gradients.<br /><br>c. Valve competence (eg, right ventricular size and function) assessed by<br /><br>noninvasive imaging tools such as echocardiography or cardiac magnetic<br /><br>resonance imaging.</p><br>