Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")

Heart Valve Disease Clinical Trial

— ARISE  

Official title:

Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527629
• Other study ID #: 2015- 01, 20.07.2015
• Secondary ID: Grant Agreement
• Status: Completed
• Start date: September 2015
• Est. completion date: March 2019

Study information

• Verified date: May 2020
• Source: corlife
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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®.

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Other:
• Decellularized human heart valves
Decellularized human aortic heart valves

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven, UZL	Leuven
Germany	University of Düsseldorf, Department of Cardiovascular Surgery	Düsseldorf
Germany	Hannover Medical School	Hannover
Italy	Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite	Padova
Netherlands	Leids Universitair Medisch Centrum, LUMC	Leiden
Spain	University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area	Barcelona
Switzerland	Kinderspital Zürich	Zürich
United Kingdom	Royal Brompton and Harefield National Health Service Trust	London

Sponsors (9)

Lead Sponsor	Collaborator
corlife	Azienda Ospedaliera di Padova, Hannover Medical School, Heinrich-Heine University, Duesseldorf, Hospital Clinic of Barcelona, Leiden University Medical Center, Royal Brompton & Harefield NHS Foundation Trust, Universitaire Ziekenhuizen Leuven, Vienna General Hospital

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Horke A, Tudorache I, Laufer G, Andreas M, Pomar JL, Pereda D, Quintana E, Sitges M, Meyns B, Rega F, Hazekamp M, Hübler M, Schmiady M, Pepper J, Rosendahl U, Lichtenberg A, Akhyari P, Jashari R, Boethig D, Bobylev D, Avsar M, Cebotari S, Haverich A, Sari — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	up to 24 months
Secondary	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
Secondary	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

External Links

•   ARISE Website