Severe Aortic Valve StenosisFORCE-AoSNCT06168123
Future Optimal Research and Care Evaluation - Aortic Stenosis
An observational study of Severe Aortic Valve Stenosis and Moderate Aortic Valve Stenosis, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Severe Aortic Valve Stenosis, Moderate Aortic Valve Stenosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Nov 2023to 1 Aug 2027
- How long will I take part?
- 4 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe or moderate aortic stenosis
Who may be able to join
- Older than 18 years of age
- Severe or moderate aortic stenosis
- No exclusion criteria are applicable to this registry
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein
Jurrien ten berg, MD PhD
About this study
In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.
Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.
- Being tested
- Quality of life questionnaires will be assessed in addition to standard care
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaires will be assessed in addition to standard careBehavioural
Quality of life questionnaires will be assessed in addition to standard care
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as assessed by the EQ-5D-5L
The EQ-5D-5L is a standardized health-related quality of life instrument that assesses individuals across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It generates a health profile that can be converted into a single index value, commonly ranging from -0.594 to 1, where 1 represents full health, 0 indicates a state equivalent to death, and negative values reflect health states perceived as worse than death.
Measured: Until completion of the study (August 1, 2027)
Quality of life as assessed by the KCCQ
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific instrument assessing heart failure patients across domains such as Total Symptoms, Physical Limitation, and Quality of Life, with scores ranging from 0 to 100. Higher scores indicate better health-related quality of life, while lower scores suggest increased symptomatology and functional limitations in heart failure patients.
Measured: Until completion of the study (August 1, 2027)
Quality of life as assessed by the SF-12
The Short Form 12 (SF-12) is a widely used health survey that measures health-related quality of life across physical and mental domains. It generates two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both ranging from 0 to 100, where higher scores indicate better health status, and these summaries provide a concise assessment of an individual's overall physical and mental well-being.
Measured: Until completion of the study (August 1, 2027)
Secondary outcomes (13)
Mortality according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Neurological events according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Hospitalisation according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Bleeding and transfusions according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Vascular and access-related complications according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Cardiac structural complications according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Other procedural or valve-related complications according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
New conduction disturbances and arrhythmias according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Acute kidney injury according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Myocardial infarction according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Bioprosthetic valve dysfunction according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Leaflet thickening and reduced motion according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Clinically significant valve thrombosis according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: Until completion of the study (August 1, 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start27 Nov 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic Valve StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurriën M. ten Berg, MD, PhD, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168123
- Sponsor's protocol ID
- Z23.069
- Acronym
- FORCE-AoS
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Optimal Research and Care Evaluation - Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06168123
- Acronym / sponsor ID
- FORCE-AoS / Z23.069
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 13 Dec 2023 (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.
In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.
Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe or moderate aortic stenosis
Key inclusion criteria (3 listed)
- Older than 18 years of age
- Severe or moderate aortic stenosis
- No exclusion criteria are applicable to this registry
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Quality of life questionnaires will be assessed in addition to standard careQuality of life questionnaires will be assessed in addition to standard care | Behavioural | – |
Primary outcome
Quality of life as assessed by the EQ-5D-5L
Time frame: Until completion of the study (August 1, 2027)
The EQ-5D-5L is a standardized health-related quality of life instrument that assesses individuals across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It generates a health profile that can be converted into a single index value, commonly ranging from -0.594 to 1, where 1 represents full health, 0 indicates a state equivalent to death, and negative values reflect health states perceived as worse than death.
Quality of life as assessed by the KCCQ
Time frame: Until completion of the study (August 1, 2027)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific instrument assessing heart failure patients across domains such as Total Symptoms, Physical Limitation, and Quality of Life, with scores ranging from 0 to 100. Higher scores indicate better health-related quality of life, while lower scores suggest increased symptomatology and functional limitations in heart failure patients.
Quality of life as assessed by the SF-12
Time frame: Until completion of the study (August 1, 2027)
The Short Form 12 (SF-12) is a widely used health survey that measures health-related quality of life across physical and mental domains. It generates two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both ranging from 0 to 100, where higher scores indicate better health status, and these summaries provide a concise assessment of an individual's overall physical and mental well-being.
13 secondary outcomes
Mortality according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Neurological events according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Hospitalisation according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Bleeding and transfusions according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Vascular and access-related complications according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Cardiac structural complications according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Other procedural or valve-related complications according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
New conduction disturbances and arrhythmias according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Acute kidney injury according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Myocardial infarction according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Bioprosthetic valve dysfunction according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Leaflet thickening and reduced motion according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
Clinically significant valve thrombosis according the VARC-3 criteria
Time frame: Until completion of the study (August 1, 2027)
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 3 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Valve Stenosis and Moderate Aortic Valve Stenosis, run by St. Antonius Hospital at 1 site in Netherlands.
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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Contact Christiaan Overduin (+31 (0)88 320 0931, c.overduin@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life as assessed by the EQ-5D-5L (time frame: Until completion of the study (August 1, 2027)). The study lists 3 primary outcomes in all. 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 3 Dec 2024.