Aortic Valve DisorderVERITASNCT01353287
Transcatheter Aortic Valve Intervention-Live Transmission
An observational study of Aortic Valve Disorder, run by Medstar Health Research Institute at 6 sites in 6 countries.
Trial summary
The primary objective of this clinical trial is to evaluate safety of patients who underwent Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission as compared to those without procedure transmission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disorder
- How many people
- 110 participants
- Where
- 6 sitesin 6 countries
- Study dates
- May 2011to Jun 2013
- 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, male or female, over 18 years of age who have either undergone live case or video-taped transmission of TAVI procedure (Case), or have undergone the procedure without procedure transmission(Control).
Cases Inclusion Criteria:
- Subjects > 18 years of age, male or female
- Subject had live case or video-taped transmission of TAVI procedure with:
Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach
Controls Inclusion Criteria:
- Subjects > 18 years of age, male or female
- Subject underwent TAVI without procedure transmission and had:
Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach
- Subjects will be matched to Cases upon the following:
- STS SCORE +/- 2points
- Date of TAVI procedure +/- 4weeks
- The first attending for the TAVI procedure
- Access site for TAVI
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia
About this study
Official title: Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
The primary objective of this clinical trial is to evaluate safety of patients who underwent Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission as compared to those without procedure transmission.
Read the detailed description
A series of sites from outside the US, where the Edwards-Sapien and CoreValve devices are approved for commercial sale and implantation, will be recruited to retrospectively identify and extract in-hospital data of a patient who underwent TAVI during a live or video-taped procedure and a matched patient who underwent TAVI without transmission of the procedure.
- Conditions
- Aortic Valve Disorder
- Keywords
- Transcatheter Aortic Valve Intervention (TAVI), Live case transmission
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TAVI live case or video-taped transmission | Not described | |
| TAVI without transmission | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DisorderStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Washington Hospital Center, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353287
- Sponsor's protocol ID
- VERITAS
- Acronym
- VERITAS
- Status last verified
- Jul 2013
- First submitted
- 11 May 2011
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
- ClinicalTrials.gov ID
- NCT01353287
- Acronym / sponsor ID
- VERITAS / VERITAS
- Conditions
- Aortic Valve Disorder
- Keywords
- Transcatheter Aortic Valve Intervention (TAVI), Live case transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- May 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 May 2011 (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 primary objective of this clinical trial is to evaluate safety of patients who underwent Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission as compared to those without procedure transmission.
Detailed description
A series of sites from outside the US, where the Edwards-Sapien and CoreValve devices are approved for commercial sale and implantation, will be recruited to retrospectively identify and extract in-hospital data of a patient who underwent TAVI during a live or video-taped procedure and a matched patient who underwent TAVI without transmission of the procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI live case or video-taped transmission | – | – |
| TAVI without transmission | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, male or female, over 18 years of age who have either undergone live case or video-taped transmission of TAVI procedure (Case), or have undergone the procedure without procedure transmission(Control).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
Time frame: Baseline
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 1 Aug 2013.
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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.
Ron Waksman, MD principal investigator
Washington Hospital Center, Washington, DC
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disorder, run by Medstar Health Research Institute at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Germany, Italy, Switzerland and 1 more country. 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?
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker. (time frame: Baseline). 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 1 Aug 2013.