Heart Valve DiseaseARISENCT02527629
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
An observational study of Heart Valve Disease, run by corlife at 8 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Decellularized human heart valves
- How many people
- 144 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Sep 2015to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe aortic valve disease and the indication for aortic valve replacement
Who may be able to join
- Indication for aortic valve replacement according to current medical guidelines in valvular heart disease
- Informed consent of legal guardians or patients, assent of patients
Who cannot join
- The patient has not provided Surveillance informed consent.
- 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.
- The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
- Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Germany2 sites
University of Düsseldorf, Department of Cardiovascular Surgery
Düsseldorf, 40225
Hannover Medical School
Hanover, 30625
Italy1 site
Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite
Padova, 35128
Spain1 site
University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area
Barcelona, 08036
United Kingdom1 site
Royal Brompton and Harefield National Health Service Trust
London, SW3 6NP
About this study
Official title: Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")
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.
Read the 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.
- Conditions
- Heart Valve Disease
- Being tested
- Decellularized human heart valves
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decellularized human heart valvesOther
Also called Arise Aortic Valve (AV)
Decellularized human aortic heart valves
| Study group | Role | What they receive |
|---|---|---|
| Decellularized human valves | Aortic heart valve replacement Receives: Other: Decellularized human heart valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: up to 24 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- corlife
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hannover Medical School, Leiden University Medical Center, Azienda Ospedaliera di Padova, Hospital Clinic of Barcelona, Royal Brompton & Harefield NHS Foundation Trust, Universitaire Ziekenhuizen KU Leuven, Heinrich-Heine University, Duesseldorf, Vienna General Hospital
- Responsible party
- Sponsor
- Investigators
- Axel Haverich, Prof. Dr., Principal investigator, Hannover Medical SchoolSamir Sarikouch, PD Dr., Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527629
- Sponsor's protocol ID
- 2015- 01, 20.07.2015
- Other IDs
- Grant Agreement No: 643597
- Acronym
- ARISE
- Status last verified
- May 2020
- First submitted
- 27 Jul 2015
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32386409Cvitkovic 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.
PubMed 41467751
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")
- ClinicalTrials.gov ID
- NCT02527629
- Acronym / sponsor ID
- ARISE / 2015- 01, 20.07.2015
- Conditions
- Heart Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- corlifeIndustry (pharma, biotech, devices)
- Collaborators
- Hannover Medical School, Leiden University Medical Center, Azienda Ospedaliera di Padova, Hospital Clinic of Barcelona, Royal Brompton & Harefield NHS Foundation Trust, Universitaire Ziekenhuizen KU Leuven, Heinrich-Heine University, Duesseldorf, Vienna General Hospital
- Study start
- Sep 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decellularized human valves | – | Other: Decellularized human heart valvesAortic heart valve replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe aortic valve disease and the indication for aortic valve replacement
Key inclusion criteria (2 listed)
- Indication for aortic valve replacement according to current medical guidelines in valvular heart disease
- Informed consent of legal guardians or patients, assent of patients
Key exclusion criteria (7 listed)
- The patient has not provided Surveillance informed consent.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decellularized human heart valvesAlso: Arise Aortic Valve (AV)Decellularized human aortic heart valves | Other | Decellularized human valves |
Primary outcome
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.
3 secondary outcomes
Evaluation of composite blood parameters
Time frame: up to 24 months
Time to reoperation and / or death
Time frame: up to 24 months
Evaluation of composite valve measures
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Results publication: PubMed 32386409Horke 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.
- Derived from this study: PubMed 41467751Cvitkovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Haverich, Prof. Dr. principal investigator
Hannover Medical School
Samir Sarikouch, PD Dr. study director
Hannover Medical School
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Disease, run by corlife at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Belgium, Italy, Netherlands, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Adverse Reactions (AR) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.