Aortic Valve DiseaseASCENDNCT05082454
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
An observational study of Aortic Valve Disease, run by JOTEC GmbH at 11 sites in 5 countries.
Trial summary
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Open repair
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 20 Oct 2021to 31 Mar 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients (≥ 18 years of age) who either underwent (US only) or will be undergoing (Europe and US) implant of the On-X AAP for aortic valve and ascending aorta replacement and who meet the criteria listed below.
Who may be able to join
- Patient ≥ 18 years of age at time of On-X AAP implant
- Patient understands and has signed the Informed Consent Form:
- Prior to implant of On-X AAP or
- Post implant (US only) or
- Patient died prior to enrollment (US only)
- Patient is willing and able to participate in follow-up
Who cannot join
- Patient unable to tolerate anticoagulation therapy
- Patient with active endocarditis at the time of his / her On-X AAP implant
- Patient participates / participated in another clinical investigation which may interfere / may have interfered with the effectiveness of anticoagulation therapy
- Patient has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
- Patients in which On-X AAP is implanted in combination with AMDS or FET
- Patient's life expectancy is less than 3 years in the opinion of the Investigator
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States3 sites
Geisinger Health System
Danville, Pennsylvania, 17822
Baylor College of Medicine
Houston, Texas, 77030
VCU Medical Center Main Hospital
Richmond, Virginia, 23298
United Kingdom3 sites
Castle Hill Hospital
Cottingham, HU16 5JQ
St Bartholomew's Hospital
London, EC1A 7B
Newcastle Freeman Hospital
Newcastle, NE7 7DN
Germany2 sites
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
University Hospital Magdeburg
Magdeburg, 39120
Spain2 sites
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: ASCEND - Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
Read the detailed description
In this study patients will be observed that receive an On-X AAP implant for the treatment of a diseased, damaged, or malfunctioning native or prosthetic heart valve. The On-X AAP will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the On-X AAP. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient in Europe and every patient that is alive in the US prior to data collection where required. In Europe, every patient will be enrolled prospectively prior to the intervention.
In the US, patients can be enrolled retrospectively after the intervention or prospectively prior to the intervention. The data from patients who have died following their implant will be recorded in the database without the requirement for written informed consent after IRB approval.
The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the surgery for each patient.
Echocardiography images at prior to discharge, at 12 months, 60 months will be evaluated by a CoreLab. All adverse events defined in the Clinical Event Committee (CEC) charter will be adjudicated by the CEC.
- Conditions
- Aortic Valve Disease
- Being tested
- Open repair
- Keywords
- aortic, valve, stenosis, thoracic, aneurysm, dissection, valved, conduit
- Medical subject headings
- Aortic Valve Disease, Constriction, Pathologic, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repairDevice
Open repair of the aortic heart valve and ascending thoracic aorta
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of in-house all-cause mortality
Measured: at discharge to home or to rehabilitation
Secondary outcomes (16)
All-cause Mortality
Rate of all-cause mortality
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve-related mortality
Rate of valve-related mortality
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Reoperation
Rate of patients with reoperation
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Explant
Rate of patients with explant of On-X AAP (including heart valve)
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Endocarditis
Rate of patients with endocarditis
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Embolism
Rate of patients with embolism
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Thromboembolism
Rate of patients with peripheral thromboembolism
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Bleeding
Rate of patients with major bleeding
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Transient ischemic attack
Rate of patients with transient ischemic attack (TIA)
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Stroke
Rate of patients with new stroke (ischemic and hemorrhagic) (mRS > mRS at baseline)
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Ischemic stroke
Rate of patients with new ischemic stroke (mRS > mRS at baseline)
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Hemorrhagic stroke
Rate of patients with new hemorrhagic stroke (mRS > mRS at baseline)
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve deterioration
Rate of patients with structural valve deterioration
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Non-structural dysfunction
Rate of patients with non-structural dysfunction
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve thrombosis
Rate of patients with valve thrombosis
Measured: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
NYHA
NYHA Functional Class
Measured: 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start20 Oct 2021
- Primary completion6 Feb 2024
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davide Pacini, Prof. Dr., Principal investigator, Policlinico S. Orsola-Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082454
- Sponsor's protocol ID
- ASCEND
- Acronym
- ASCEND
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASCEND - Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
- ClinicalTrials.gov ID
- NCT05082454
- Acronym / sponsor ID
- ASCEND / ASCEND
- Conditions
- Aortic Valve Disease
- Keywords
- aortic, valve, stenosis, thoracic, aneurysm, dissection, valved, conduit
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 19 Oct 2021 (actual)
- 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.
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
Detailed description
In this study patients will be observed that receive an On-X AAP implant for the treatment of a diseased, damaged, or malfunctioning native or prosthetic heart valve. The On-X AAP will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the On-X AAP. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient in Europe and every patient that is alive in the US prior to data collection where required. In Europe, every patient will be enrolled prospectively prior to the intervention.
In the US, patients can be enrolled retrospectively after the intervention or prospectively prior to the intervention. The data from patients who have died following their implant will be recorded in the database without the requirement for written informed consent after IRB approval.
The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the surgery for each patient.
Echocardiography images at prior to discharge, at 12 months, 60 months will be evaluated by a CoreLab. All adverse events defined in the Clinical Event Committee (CEC) charter will be adjudicated by the CEC.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients (≥ 18 years of age) who either underwent (US only) or will be undergoing (Europe and US) implant of the On-X AAP for aortic valve and ascending aorta replacement and who meet the criteria listed below.
Key inclusion criteria (6 listed)
- Patient ≥ 18 years of age at time of On-X AAP implant
- Patient understands and has signed the Informed Consent Form:
- Patient is willing and able to participate in follow-up
Key exclusion criteria (6 listed)
- Patient unable to tolerate anticoagulation therapy
- Patient with active endocarditis at the time of his / her On-X AAP implant
- Patient participates / participated in another clinical investigation which may interfere / may have interfered with the effectiveness of anticoagulation therapy
- Patient has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
- Patients in which On-X AAP is implanted in combination with AMDS or FET
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 |
|---|---|---|
| Open repairOpen repair of the aortic heart valve and ascending thoracic aorta | Device | – |
Primary outcome
Mortality
Time frame: at discharge to home or to rehabilitation
Rate of in-house all-cause mortality
16 secondary outcomes
All-cause Mortality
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve-related mortality
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Reoperation
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Explant
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Endocarditis
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Embolism
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Thromboembolism
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Bleeding
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Transient ischemic attack
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Stroke
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Ischemic stroke
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Hemorrhagic stroke
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve deterioration
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Non-structural dysfunction
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve thrombosis
Time frame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
NYHA
Time frame: 1 year, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Davide Pacini, Prof. Dr. principal investigator
Policlinico S. Orsola-Malpighi
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by JOTEC GmbH at 11 sites in 5 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom, Germany, Spain, Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality (time frame: at discharge to home or to rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.