Atrial FibrillationLARIATNCT02309268
Atrial Appendage Closure Prospective Observational Study
An observational study of Atrial Fibrillation and Left Atrial Appendage Closure, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Closure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being asked to take part in this study have a heart disorder known as atrial fibrillation (AF) and are poor candidates to take blood thinning drug known as warfarin (Coumadin), and have elected to undergo LARIAT procedure.
Who may be able to join
- Patients with Atrial fibrillation
- Are poor candidates to take warfarin
- Have elected to undergo a LARIAT procedure
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LARIAT: Atrial Appendage Closure Prospective Observational Study
The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).
Read the detailed description
Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure
- Keywords
- left atrial appendage closure
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Progress
Patients who agree to participate in the registry will allow the Investigators to document their clinical progress and compare their progress to other participants in the study. Meanwhile, the patient will continue to receive routine care from their physician, just as they would if they did not participate in the study. Any information published as a result of this registry, will be kept anonymous. There is no known risk in participating in this study as it is only an observational study.
Measured: At regular visits ( 3 months and annually)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: The principal linvestigator decided not to continue the registry. No patient were enrolled. CLosure to the registry was done October 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kenneth A Ellenbogen, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309268
- Sponsor's protocol ID
- LARIAT
- Acronym
- LARIAT
- Status last verified
- Jun 2015
- First submitted
- 1 Aug 2014
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LARIAT: Atrial Appendage Closure Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02309268
- Acronym / sponsor ID
- LARIAT / LARIAT
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure
- Keywords
- left atrial appendage closure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The principal linvestigator decided not to continue the registry. No patient were enrolled. CLosure to the registry was done October 2014
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Dec 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 research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).
Detailed description
Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being asked to take part in this study have a heart disorder known as atrial fibrillation (AF) and are poor candidates to take blood thinning drug known as warfarin (Coumadin), and have elected to undergo LARIAT procedure.
Key inclusion criteria (3 listed)
- Patients with Atrial fibrillation
- Are poor candidates to take warfarin
- Have elected to undergo a LARIAT procedure
Key exclusion criteria (1 listed)
- none
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
Clinical Progress
Time frame: At regular visits ( 3 months and annually)
Patients who agree to participate in the registry will allow the Investigators to document their clinical progress and compare their progress to other participants in the study. Meanwhile, the patient will continue to receive routine care from their physician, just as they would if they did not participate in the study. Any information published as a result of this registry, will be kept anonymous. There is no known risk in participating in this study as it is only an observational study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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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 A Ellenbogen, MD principal investigator
Virginia Commonwealth 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 Atrial Fibrillation and Left Atrial Appendage Closure, run by Virginia Commonwealth University 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 3 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: withdrawn, as of the sponsor's last update on 15 Jun 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Progress (time frame: At regular visits ( 3 months and annually)). 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 15 Jun 2015.