Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap
Recruiting
- Conditions
- Aortic Valve Disease10046973
- Registration Number
- NL-OMON43320
- 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 aortic valve replacement according to current medical guidelines in valvular 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 (e.g. 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>1. Cardiovascular Adverse Reactions, e.g. all-cause mortality, major stroke,<br /><br>life-threatening (or disabling) bleeding, acute kidney injury-stage 3<br /><br>(including renal replacement therapy), peri-procedural myocardial infarction,<br /><br>major vascular complication, repeat procedure for valve-related dysfunction<br /><br>(surgical or interventional therapy).<br /><br>2. Serious Adverse Reactions, e.g. infections, immunological reactions, etc.<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>1. Blood parameters as additional safety data to support presence/absence of<br /><br>adverse reactions.<br /><br>2. Time to reoperation, explantation and/or death.<br /><br><br /><br>Secondary efficacy endpoints (i.e. at end of the study in comparison to at<br /><br>implantation):<br /><br>1. Diameters of the ARISE AV.<br /><br>2. Transvalvular gradients.<br /><br>3. Valve competence assessed by noninvasive imaging tools such as<br /><br>echocardiography or cardiac magnetic resonance imaging.</p><br>