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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
Sponsor:
Collaborators:
Hannover Medical School
Leiden University Medical Center
Azienda Ospedaliera di Padova
Hospital Clinic of Barcelona
Royal Brompton & Harefield NHS Foundation Trust
Universitaire Ziekenhuizen Leuven
Heinrich-Heine University, Duesseldorf
Vienna General Hospital
Information provided by (Responsible Party):
corlife

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Decellularized human valves
Aortic heart valve replacement
Other: Decellularized human heart valves
Decellularized human aortic heart valves
Other Name: Arise Aortic Valve (AV)




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe aortic valve disease and the indication for aortic valve replacement
Criteria

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:

  • generalized connective tissue disorders (eg, Marfan syndrome), or .
  • active rheumatic disorders, or
  • severe asymmetric calcification of the valve ring.

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®.


Information from the National Library of Medicine

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


Locations
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Belgium
Universitair Ziekenhuis Leuven, UZL
Leuven, Belgium, 3000
Germany
University of Düsseldorf, Department of Cardiovascular Surgery
Düsseldorf, Germany, 40225
Hannover Medical School
Hannover, Germany, 30625
Italy
Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite
Padova, Italy, 35128
Netherlands
Leids Universitair Medisch Centrum, LUMC
Leiden, Netherlands, 2333
Spain
University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area
Barcelona, Spain, 08036
Switzerland
Kinderspital Zürich
Zürich, Switzerland, 8032
United Kingdom
Royal Brompton and Harefield National Health Service Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
corlife
Hannover Medical School
Leiden University Medical Center
Azienda Ospedaliera di Padova
Hospital Clinic of Barcelona
Royal Brompton & Harefield NHS Foundation Trust
Universitaire Ziekenhuizen Leuven
Heinrich-Heine University, Duesseldorf
Vienna General Hospital
Investigators
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Principal Investigator: Axel Haverich, Prof. Dr. Hannover Medical School
Study Director: Samir Sarikouch, PD Dr. Hannover Medical School

Additional Information:
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Responsible Party: corlife
ClinicalTrials.gov Identifier: NCT02527629     History of Changes
Other Study ID Numbers: 2015- 01, 20.07.2015
Grant Agreement No: 643597 ( Other Grant/Funding Number: European Commission )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases