Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance") (ARISE)
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|ClinicalTrials.gov Identifier: NCT02527629|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : August 12, 2019
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.
|Condition or disease||Intervention/treatment|
|Heart Valve Disease||Other: Decellularized human heart valves|
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
- ARISE AV is prescribed in the usual manner in accordance with the terms of the approval.
- 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 ARISE AV 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.
|Study Type :||Observational|
|Actual Enrollment :||144 participants|
|Official Title:||Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||March 2019|
Decellularized human valves
Aortic heart valve replacement
Other: Decellularized human heart valves
Decellularized human aortic heart valves
Other Name: Arise Aortic Valve (AV)
- Cardiovascular Adverse Reactions (AR) [ Time Frame: up to 24 months ]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).
- Freedom from valve dysfunction at end of the study [ Time Frame: up to 24 months ]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.
- Evaluation of composite blood parameters [ Time Frame: up to 24 months ]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.
- Time to reoperation and / or death [ Time Frame: up to 24 months ]Time to events, such as death, reoperation including explantation will be evaluated for those outcomes, calculated from the date of operation
- Evaluation of composite valve measures [ Time Frame: up to 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527629
|Universitair Ziekenhuis Leuven, UZL|
|Leuven, Belgium, 3000|
|University of Düsseldorf, Department of Cardiovascular Surgery|
|Düsseldorf, Germany, 40225|
|Hannover Medical School|
|Hannover, Germany, 30625|
|Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite|
|Padova, Italy, 35128|
|Leids Universitair Medisch Centrum, LUMC|
|Leiden, Netherlands, 2333|
|University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area|
|Barcelona, Spain, 08036|
|Zürich, Switzerland, 8032|
|Royal Brompton and Harefield National Health Service Trust|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Axel Haverich, Prof. Dr.||Hannover Medical School|
|Study Director:||Samir Sarikouch, PD Dr.||Hannover Medical School|