Aortic Valve DiseaseCAvEATNCT04647864
The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI
An observational study of Aortic Valve Disease, run by University of Padova at 1 site in Italy.
Trial summary
The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is… 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?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2021to 1 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation), who are candidate to TAVI according to local Heart Team evaluation. Valve-in-valve procedure due to degeneration of a previously implanted surgical bio prosthesis are also included in this study population. All consecutive patients who undergo coronary access immediately after TAVI will be enrolled in this study.
Who may be able to join
- Symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation) candidate to TAVI according to local Heart Team evaluation, including valve-in-valve procedure due to degeneration of a previously implanted surgical bioprosthesis, who undergo coronary access in the same session of TAVI, immediately after transcatheter valve deployment (the procedures have to be consecutive);
- Provision of signed informed consent;
- Age ≥18 Years.
Who cannot join
- Chronic Kidney Disease stage IV-V (without dialytic treatment; otherwise, patients in dialytic treatment could be included);
- Current participation in an interventional clinical study;
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedale Università Padova
Padova
Giuseppe Tarantini
Giuseppe Tarantini
About this study
The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is a significant difference among different type of transcatheter valves in selective coronary cannulation.
- Conditions
- Aortic Valve Disease
- Being tested
- Transcatheter Aortic Valve Implantation
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationDevice
Also called Transcatheter Aortic Valve Replacement, Percutaneous aortic valve replacement (PAVR), Percutaneous aortic valve implantation (PAVI)
Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Edwards Sapien 3 and Edwards Sapien 3 Ultra Receives: Device: Transcatheter Aortic Valve Implantation | |
| Group 2 | Medtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO Receives: Device: Transcatheter Aortic Valve Implantation | |
| Group 3 | Boston Scientific Acurate neo and Boston Scientific Acurate neo2 Receives: Device: Transcatheter Aortic Valve Implantation | |
| Group 4 | St. Jude Medical Portico Receives: Device: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful selective cannulation of both coronary arteries
Successful selective cannulation of both coronary arteries
Measured: Immediately after TAVI
Secondary outcomes (2)
Successful selective cannulation of only left coronary artery
Successful selective cannulation of only left coronary artery (and no cannulation or sub selective cannulation of the contralateral)
Measured: Immediately after TAVI
Successful selective cannulation of only right coronary artery
Successful selective cannulation of only right coronary artery (and no cannulation or sub selective cannulation of the contralateral)
Measured: Immediately after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start28 Jan 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (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.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione GISE Onlus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647864
- Sponsor's protocol ID
- CAvEAT
- Acronym
- CAvEAT
- Status last verified
- Jul 2021
- First submitted
- 24 Nov 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI
- ClinicalTrials.gov ID
- NCT04647864
- Acronym / sponsor ID
- CAvEAT / CAvEAT
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Fondazione GISE Onlus
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 1 Dec 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.
The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is a significant difference among different type of transcatheter valves in selective coronary cannulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Transcatheter Aortic Valve ImplantationEdwards Sapien 3 and Edwards Sapien 3 Ultra |
| Group 2 | – | Device: Transcatheter Aortic Valve ImplantationMedtronic Corevalve Evolut R and Medtronic Corevalve Evolut PRO |
| Group 3 | – | Device: Transcatheter Aortic Valve ImplantationBoston Scientific Acurate neo and Boston Scientific Acurate neo2 |
| Group 4 | – | Device: Transcatheter Aortic Valve ImplantationSt. Jude Medical Portico |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation), who are candidate to TAVI according to local Heart Team evaluation. Valve-in-valve procedure due to degeneration of a previously implanted surgical bio prosthesis are also included in this study population. All consecutive patients who undergo coronary access immediately after TAVI will be enrolled in this study.
Key inclusion criteria (3 listed)
- Symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation) candidate to TAVI according to local Heart Team evaluation, including valve-in-valve procedure due to degeneration of a previously implanted surgical bioprosthesis, who undergo coronary access in the same session of TAVI, immediately after transcatheter valve deployment (the procedures have to be consecutive);
- Provision of signed informed consent;
- Age ≥18 Years.
Key exclusion criteria (3 listed)
- Chronic Kidney Disease stage IV-V (without dialytic treatment; otherwise, patients in dialytic treatment could be included);
- Current participation in an interventional clinical study;
- Age < 18 years.
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationAlso: Transcatheter Aortic Valve Replacement, Percutaneous aortic valve replacement (PAVR), Percutaneous aortic valve implantation (PAVI)Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods. | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Successful selective cannulation of both coronary arteries
Time frame: Immediately after TAVI
Successful selective cannulation of both coronary arteries
2 secondary outcomes
Successful selective cannulation of only left coronary artery
Time frame: Immediately after TAVI
Successful selective cannulation of only right coronary artery
Time frame: Immediately after TAVI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- 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. This study is not recruiting at the moment.
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 Disease, run by University of Padova at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Martinato, PhD (+390498275646, matteo.martinato@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful selective cannulation of both coronary arteries (time frame: Immediately after TAVI). 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 16 Jul 2021.