Aortic StenosisPhase 3CT-TAVINCT01672268
Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI
A Phase 3 study testing cardiac computed tomography in people with Aortic Stenosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- cardiac computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Nov 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis
- male or female patient, older than eighteen years old
- who have given their written consent
- who are affiliated to the French social security system
- which has a too high risk of surgical valvular replacement (EuroSCORE logistic > 20% or Society of Thoracic Surgeons Score > 10, or contre indicated to a cardiac surgery by a heart team
- Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure
Who cannot join
- Patient who can't give his written consent because of his physical or mental status
- Adult patient protect by law (article L1121-8),
- Person deprived of liberty (article L1121-8),
- Pregnant women
- Patient in terminal phase of illness,
- Terminal kidney failure
Show all 12Show fewer
- Allergy to iodine
- bicuspids ou unicuspid aortic,
- Diameter of the left ventricular outflow tract < 18mm or > 25mm,
- Diameter of the femoral artery < 7mm, tortuosity or calcifications
- Septal hypertrophy
- Apical thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)
This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).
Read the detailed description
The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.
- Conditions
- Aortic Stenosis
- Being tested
- cardiac computed tomography
- Keywords
- cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
- 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.
cardiac computed tomographyOther
Also called Transcatheter Aortic Valve Implantation
cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
| Study group | Role | What they receive |
|---|---|---|
| Standard TAVI procedure | Active comparator | Patients without Cardiac CT measures before TAVI Receives: Other: cardiac computed tomography |
| Cardiac CT scan before TAVI procedure | Experimental | patients with cardiac CT measures before TAVI Receives: Other: cardiac computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end point
Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography
Measured: participants will be followed for the duration of 1 year
Secondary outcomes (3)
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
- Size of the aortic annulus/ diameter and area
Measured: inclusion visit
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
- Left ventricular outflow tract, anatomy of the aortic roots
Measured: inclusion visit
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
- Left ventricular function, size, volume
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles MD BARONE ROCHETTE, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672268
- Sponsor's protocol ID
- 2011-A001113-38
- Other IDs
- 2011-A001113-38
- Acronym
- CT-TAVI
- Status last verified
- Apr 2012
- First submitted
- 18 Apr 2012
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT01672268
- Acronym / sponsor ID
- CT-TAVI / 2011-A001113-38
- Conditions
- Aortic Stenosis
- Keywords
- cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Aug 2012 (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.
This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).
Detailed description
The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard TAVI procedure | Active comparator | Other: cardiac computed tomographyPatients without Cardiac CT measures before TAVI |
| Cardiac CT scan before TAVI procedure | Experimental | Other: cardiac computed tomographypatients with cardiac CT measures before TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis
- male or female patient, older than eighteen years old
- who have given their written consent
- who are affiliated to the French social security system
- which has a too high risk of surgical valvular replacement (EuroSCORE logistic > 20% or Society of Thoracic Surgeons Score > 10, or contre indicated to a cardiac surgery by a heart team
Key exclusion criteria (12 listed)
- Patient who can't give his written consent because of his physical or mental status
- Adult patient protect by law (article L1121-8),
- Person deprived of liberty (article L1121-8),
- Pregnant women
- Patient in terminal phase of illness,
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 |
|---|---|---|
| cardiac computed tomographyAlso: Transcatheter Aortic Valve Implantationcardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy | Other | Cardiac CT scan before TAVI procedure, Standard TAVI procedure |
Primary outcome
Composite end point
Time frame: participants will be followed for the duration of 1 year
Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography
3 secondary outcomes
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Time frame: inclusion visit
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Time frame: inclusion visit
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Time frame: inclusion visit
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 25 Nov 2014.
Related trials for Aortic Stenosis
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
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.
Gilles MD BARONE ROCHETTE principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cardiac computed tomography in people with Aortic Stenosis, run by University Hospital, Grenoble at 1 site in France.
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 12 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 25 Nov 2014. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite end point (time frame: participants will be followed for the duration of 1 year). 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 25 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.