Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Grant Agreement No: 643597 | Other Grant/Funding Number | European Commission |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
| Leiden University Medical Center | OTHER |
| Azienda Ospedaliera di Padova | OTHER |
| Hospital Clinic of Barcelona |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of decellularized human heart valves for aortic 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.
This is a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in Europe.
The Surveillance is designed as a study, where
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decellularized human valves | Aortic heart valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decellularized human heart valves | Other | Decellularized human aortic heart valves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Adverse Reactions (AR) | Rate of cardiovascular AR, e.g. all-cause mortality, major stroke, life-threatening (or disabling) bleeding, acute kidney injury-stage 3 (including renal replacement therapy), peri-procedural myocardial infarction, major vascular complication, repeat procedure for valve-related dysfunction (surgical or interventional therapy). | up to 24 months |
| Freedom from valve dysfunction at end of the study | Echocardiographic studies should be obtained and analyzed at discharge and at 3, 6 Months and at annual follow-ups. The requested variables include peak and mean systolic gradient, using pw and cw doppler, in the left ventricular outflow tract, respective the aortic valve. The echo evaluation (videotape or CD) should remain at the Surveillance site, but be available to corlife Surveillance personnel upon request. The MRIs will be analyzed by the MRI Core Laboratory at Medical School in Hannover for potential valvular stenosis, via phase contrast flow measurements in the aorta and for valvular competence, via phase contrast flow measurements and by ventricular volumetry. MRI cine images will be used to visualize the Surveillance valve in patients with poor echocardiographic windows. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of composite blood parameters | The following data should be collected: Hb, LDH, Haptoglobin, CRP, Leukocytes. Blood studies should be performed within 7 days preoperatively and at discharge. Blood data will support the absence/presence of related AR. For example, haemolysis should be reported as an adverse event if anaemia is present; however, in the absence of anaemia, haemolysis will be considered to be compensated and does not require reporting. Time to events, such as death, reoperation including explantation will be evaluated for those outcomes, calculated from the date of operation. |
Not provided
Inclusion Criteria:
i. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease
ii. Informed consent of legal guardians or patients, assent of patients
Exclusion Criteria:
i. The patient has not provided Surveillance informed consent.
ii. The patient shall not suffer from:
iii. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
iv. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Not provided
Not provided
Not provided
Not provided
Patients with severe aortic valve disease and the indication for aortic valve replacement
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Axel Haverich, Prof. Dr. | Hannover Medical School | Principal Investigator |
| Samir Sarikouch, PD Dr. | Hannover Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Leuven, UZL | Leuven | 3000 | Belgium | |||
| University of Düsseldorf, Department of Cardiovascular Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32386409 | Result | Horke A, Tudorache I, Laufer G, Andreas M, Pomar JL, Pereda D, Quintana E, Sitges M, Meyns B, Rega F, Hazekamp M, Hubler M, Schmiady M, Pepper J, Rosendahl U, Lichtenberg A, Akhyari P, Jashari R, Boethig D, Bobylev D, Avsar M, Cebotari S, Haverich A, Sarikouch S. Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data. Eur J Cardiothorac Surg. 2020 Nov 1;58(5):1045-1053. doi: 10.1093/ejcts/ezaa100. | |
| 41467751 |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Study results | View IPD |
Not provided
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| OTHER |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
| Vienna General Hospital | OTHER |
Not provided
Not provided
Not provided
| up to 24 months |
| Time to reoperation and / or death | Time to events, such as death, reoperation including explantation will be evaluated for those outcomes, calculated from the date of operation | up to 24 months |
| Evaluation of composite valve measures | Diameters of ARISE AV at end of the Surveillance will be analyzed in comparison to diameters at implantation and to age matched reference values. Preoperative non-invasive data on left ventricular size and function, such as left ventricular end diastolic, end systolic volume, ejection fraction and ventricular mass will be derived from MRI and compared to postoperative status. | up to 24 months |
| Düsseldorf |
| 40225 |
| Germany |
| Hannover Medical School | Hanover | 30625 | Germany |
| Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite | Padova | 35128 | Italy |
| Leids Universitair Medisch Centrum, LUMC | Leiden | 2333 | Netherlands |
| University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area | Barcelona | 08036 | Spain |
| Kinderspital Zürich | Zurich | 8032 | Switzerland |
| Royal Brompton and Harefield National Health Service Trust | London | SW3 6NP | United Kingdom |
| Derived |
| Cvitkovic T, Horke A, Bobylev D, Avsar M, Holst T, Beerbaum P, Boethig D, Petena E, Tsimashok V, Westhoff-Bleck M, Gutberlet M, Beyer FH, Wacker F, Ruhparwar A, Vogel-Claussen J, Sarikouch S, Czerner C. Aortic Compliance After Root Replacement With Decellularized Homografts Versus in Donor Age-Matched Healthy Controls. Interdiscip Cardiovasc Thorac Surg. 2026 Jan 6;41(1):ivaf303. doi: 10.1093/icvts/ivaf303. |