Aortic Valve StenosisNCT04385459
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
An observational study of Aortic Valve Stenosis and Coronary Artery Disease, run by Örebro County Council at 1 site in Sweden.
Trial summary
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Coronary Artery Disease
- What is being tested?
- Coronary artery disease
- How many people
- 346 participants
- Where
- 1 siteSweden
- Study dates
- 13 Dec 2018to 24 Dec 2020
- 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 that underwent a TAVI procedure at Örebro University Hospital between the time period 2009 till 1st december 2019 were included.
Who may be able to join
- All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.
Who cannot join
- Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital
Örebro, 70185
About this study
Official title: Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.
Read the detailed description
A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.
Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Being tested
- Coronary artery disease
- Keywords
- Aortic valve stenosis, Coronary artery disease, Transcatheter aortic valve implantation, Mortality
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery diseaseOther
Exposure
| Study group | Role | What they receive |
|---|---|---|
| Patients without coronary artery disease | No prior coronary intervention and no significant stenosis noted during coronary angiography. | |
| Patients with coronary artery disease | Our definition of coronary artery disease is:
* Prior coronary artery bypass grafting or percutaneous coronary intervention
* Significant stenosis or occlusion noted during coronary angiography Receives: Other: Coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death after the procedure
Measured: Five years.
Secondary outcomes (1)
Factors associated with less favorable early and late mortality
Factors such as renal function or comorbidities associated with higher mortality.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start13 Dec 2018
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ninos Samano M.D., Örebro County Council
- Investigators
- Ninos Samano, MD,PhD, Principal investigator, Department of Cardiothoracic and Vascular Surgery, Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385459
- Sponsor's protocol ID
- 273468
- Status last verified
- Sep 2021
- First submitted
- 6 May 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04385459
- Acronym / sponsor ID
- 273468
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Keywords
- Aortic valve stenosis, Coronary artery disease, Transcatheter aortic valve implantation, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 13 May 2020 (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.
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.
Detailed description
A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.
Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without coronary artery disease | – | –No prior coronary intervention and no significant stenosis noted during coronary angiography. |
| Patients with coronary artery disease | – | Other: Coronary artery diseaseOur definition of coronary artery disease is: * Prior coronary artery bypass grafting or percutaneous coronary intervention * Significant stenosis or occlusion noted during coronary angiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that underwent a TAVI procedure at Örebro University Hospital between the time period 2009 till 1st december 2019 were included.
Key inclusion criteria (1 listed)
- All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.
Key exclusion criteria (1 listed)
- Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.
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 |
|---|---|---|
| Coronary artery diseaseExposure | Other | Patients with coronary artery disease |
Primary outcome
Mortality
Time frame: Five years.
Death after the procedure
1 secondary outcome
Factors associated with less favorable early and late mortality
Time frame: Five years
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 9 Sep 2021.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Ninos Samano, MD,PhD principal investigator
Department of Cardiothoracic and Vascular Surgery, Örebro University
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 Aortic Valve Stenosis and Coronary Artery Disease, run by Örebro County Council at 1 site in Sweden.
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 1 inclusion and 1 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 9 Sep 2021. 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 Sweden. 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?
Mortality (time frame: Five years.). 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 9 Sep 2021.