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

NCT02527629 | Completed DMC

• 2 other identifiers: 2015- 01, 20.07.2015Grant Agreement No: 643597
• Study Type: observational
• Target: 144
• Locations: 7 countries
• Sites: 8

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.

Conditions

Heart Valve Disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Evaluation of composite blood parameters

  up to 24 months

• Time to reoperation and / or death

  up to 24 months

• Evaluation of composite valve measures

  up to 24 months

Study Arms (1)

Decellularized human valves

Aortic heart valve replacement

Other: Decellularized human heart valves

Interventions

Decellularized human heart valves OTHER

Decellularized human aortic heart valves

Also known as: Arise Aortic Valve (AV)

Decellularized human valves

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic valve disease and the indication for aortic valve replacement

You may qualify if:

• 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

You may not qualify if:

• 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®.

Sponsors & Collaborators

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

Study Sites (8)

Universitair Ziekenhuis Leuven, UZL

Leuven, 3000, Belgium

Location

University of Düsseldorf, Department of Cardiovascular Surgery

Düsseldorf, 40225, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite

Padua, 35128, Italy

Location

Leids Universitair Medisch Centrum, LUMC

Leiden, 2333, Netherlands

Location

University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area

Barcelona, 08036, Spain

Location

Kinderspital Zürich

Zurich, 8032, Switzerland

Location

Royal Brompton and Harefield National Health Service Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32386409 RESULT

• 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.

  PMID: 41467751 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Axel Haverich, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

• Samir Sarikouch, PD Dr.

  Hannover Medical School

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 19, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

DE (2); IT (1); BE (1); ES (1); CH (1); NL (1); GB (1)