Aortic Valve DiseaseCAVARECNCT02031796
Cardiac Vascular Reconstruction DynaCT for TAVI Procedures
A study testing CAVAREC Image Processing algorithm in people with Aortic Valve Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures or interventional procedures to treat congenital or structural heart disease. 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?
- CAVAREC Image Processing algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 17 Oct 2017
- Phase
- Interventional
- 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
- Patients may either be scheduled for a TAVI procedure or scheduled for a cath lab appointment at any time after a TAVI procedure, or scheduled for device implant to treat congenital or structural heart disease.
Who cannot join
- Patient enrolled in research protocol with exclusions from simultaneous participation in another protocol
- Lack of research consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures
The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures or interventional procedures to treat congenital or structural heart disease. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the interventional procedure after the TAVI device, other valve, or stent is implanted. If the participants already have a surgically-implanted TAVI device, stent or other device, and are having a cardiac catheterization, then an extra set of images will be acquired after your clinical care is complete, but before you leave the procedure room. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the interventional procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT and cardiac CT images from Radiology. The results of this study will be used to direct further development of CAVAREC toward the end goal of providing improved imaging capabilities to guide TAVI, congenital heart, or structural heart treatment procedures.
Read the detailed description
- Compare utility of CAVAREC to standard DynaCT and cardiac CT for clinical assessment of the aortic valve and relevant, nearby anatomical structures.
- Investigate the utility of CAVAREC to assess calcification within and surrounding the native aortic valve.
- Investigate the utility of CAVAREC to assess procedural success, including prosthetic valve placement and annular anatomic correlates of paravalvular leak.
- Validate utility of CAVAREC for images acquired during normal sinus rhythm.
- Conditions
- Aortic Valve Disease
- Being tested
- CAVAREC Image Processing algorithm
- 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.
CAVAREC Image Processing algorithmOther
After deployment of the TAVI prosthesis, other trans catheter valve, or stent, but before the patient care episode is completed, a set of rotational x-ray angiography images will be acquired and reconstructed using the clinical DyanCT and research CAVAREC algorithms.
| Study group | Role | What they receive |
|---|---|---|
| CAVAREC images | Experimental | CAVAREC images from x-ray angiography Receives: Other: CAVAREC Image Processing algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of images of the aortic valve that are accurate
Qualitative image assessment will be performed by Board Certified Cardiologists and/or Radiologists who are familiar with cardiac CT image manipulation and interpretation.
Measured: approx 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion13 Oct 2017
- Study completion17 Oct 2017
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 Mayo ClinicThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions USA - CSG
- Responsible party
- Principal investigator, Kenneth A. Fetterly, Ph.D., Mayo Clinic
- Investigators
- Kenneth Fetterly, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031796
- Sponsor's protocol ID
- 13-004257
- Acronym
- CAVAREC
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2014
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures
- ClinicalTrials.gov ID
- NCT02031796
- Acronym / sponsor ID
- CAVAREC / 13-004257
- Conditions
- Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions USA - CSG
- Study start
- Feb 2014
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 9 Jan 2014 (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.
The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures or interventional procedures to treat congenital or structural heart disease. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the interventional procedure after the TAVI device, other valve, or stent is implanted. If the participants already have a surgically-implanted TAVI device, stent or other device, and are having a cardiac catheterization, then an extra set of images will be acquired after your clinical care is complete, but before you leave the procedure room. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the interventional procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT and cardiac CT images from Radiology. The results of this study will be used to direct further development of CAVAREC toward the end goal of providing improved imaging capabilities to guide TAVI, congenital heart, or structural heart treatment procedures.
Detailed description
- Compare utility of CAVAREC to standard DynaCT and cardiac CT for clinical assessment of the aortic valve and relevant, nearby anatomical structures.
- Investigate the utility of CAVAREC to assess calcification within and surrounding the native aortic valve.
- Investigate the utility of CAVAREC to assess procedural success, including prosthetic valve placement and annular anatomic correlates of paravalvular leak.
- Validate utility of CAVAREC for images acquired during normal sinus rhythm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAVAREC images | Experimental | Other: CAVAREC Image Processing algorithmCAVAREC images from x-ray angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients may either be scheduled for a TAVI procedure or scheduled for a cath lab appointment at any time after a TAVI procedure, or scheduled for device implant to treat congenital or structural heart disease.
Key exclusion criteria (2 listed)
- Patient enrolled in research protocol with exclusions from simultaneous participation in another protocol
- Lack of research consent.
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 |
|---|---|---|
| CAVAREC Image Processing algorithmAfter deployment of the TAVI prosthesis, other trans catheter valve, or stent, but before the patient care episode is completed, a set of rotational x-ray angiography images will be acquired and reconstructed using the clinical DyanCT and research CAVAREC algorithms. | Other | CAVAREC images |
Primary outcome
Number of images of the aortic valve that are accurate
Time frame: approx 2 hours after surgery
Qualitative image assessment will be performed by Board Certified Cardiologists and/or Radiologists who are familiar with cardiac CT image manipulation and interpretation.
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 8 Jan 2019.
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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.
Kenneth Fetterly, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAVAREC Image Processing algorithm in people with Aortic Valve Disease, run by Mayo Clinic at 1 site in United States.
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 2 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 8 Jan 2019. 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 United States. 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?
Number of images of the aortic valve that are accurate (time frame: approx 2 hours after surgery). 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 8 Jan 2019.