Atrial FibrillationNCT01695564
Safety and Efficacy of Left Atrial Appendage Occlusion Devices
An observational study of Atrial Fibrillation, run by Kansas City Heart Rhythm Institute at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LARIAT LAA and WATCHMAN
- Type of treatment
- Medical device
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2018
- 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 who have had a LARIAT LAA device occlusion.
Who may be able to join
- Patients who have had a LARIAT LAA device occlusion
Who cannot join
- Patients who have PFO/ASD/critical carotid artery (>70% blockage) disease and hemorrhagic strokes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices
Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke compared with those without AF.
This registry will collection information on two devices that are used to treat AF. The WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices on outcomes related to AF has not been studied. This study will look to compare the two devices to see how the outcomes may vary.
- Conditions
- Atrial Fibrillation
- Being tested
- LARIAT LAA, WATCHMAN
- Keywords
- atrial enlargement, left atrial appendage
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARIAT LAADevice
The LARIAT snare device is an over-the-wire device guided over the LAA to enable ligation of the LAA. The LARIAT can be opened and closed as desired for ideal positioning without risk of suture deployment.
WATCHMANDevice
The WATCHMAN is an expandable device deployed in the LAA via a trans-septal catheter. The implanted device has a self-expanding nitinol frame to secure it in the LAA. The fabric of the WATCHMAN device is permeable to blood.
| Study group | Role | What they receive |
|---|---|---|
| WATCHMAN | Patients that had the WATCHMAN device implanted Receives: Device: WATCHMAN | |
| LARIAT LAA Device | patients that had LARIAT LAA device implanted Receives: Device: LARIAT LAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of LAA occlusion by LARIAT device
This registry will provide data on patient outcomes at different times during follow up. This includes: changes in the appendage size, shape and patients medical history.
Measured: Change from Day 0 to Day 90
Effect of LAA occlusion by LARIAT device
This registry will provide data on patient outcomes at different times during follow up.This includes: changes in the appendage size, shape and patients medical history.
Measured: Change from Day 0 to 356 post-procedure
Secondary outcomes (1)
Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities
Measured: Days 0, 90, 180, 365 post-procedure and annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2017
- Study completionFeb 2018
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.
- 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695564
- Sponsor's protocol ID
- 13240
- Status last verified
- Apr 2019
- First submitted
- 5 Jul 2012
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices
- ClinicalTrials.gov ID
- NCT01695564
- Acronym / sponsor ID
- 13240
- Conditions
- Atrial Fibrillation
- Keywords
- atrial enlargement, left atrial appendage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm InstituteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 28 Sep 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.
Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke compared with those without AF.
This registry will collection information on two devices that are used to treat AF. The WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices on outcomes related to AF has not been studied. This study will look to compare the two devices to see how the outcomes may vary.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WATCHMAN | – | Device: WATCHMANPatients that had the WATCHMAN device implanted |
| LARIAT LAA Device | – | Device: LARIAT LAApatients that had LARIAT LAA device implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a LARIAT LAA device occlusion.
Key inclusion criteria (1 listed)
- Patients who have had a LARIAT LAA device occlusion
Key exclusion criteria (1 listed)
- Patients who have PFO/ASD/critical carotid artery (>70% blockage) disease and hemorrhagic strokes
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 |
|---|---|---|
| LARIAT LAAThe LARIAT snare device is an over-the-wire device guided over the LAA to enable ligation of the LAA. The LARIAT can be opened and closed as desired for ideal positioning without risk of suture deployment. | Device | LARIAT LAA Device |
| WATCHMANThe WATCHMAN is an expandable device deployed in the LAA via a trans-septal catheter. The implanted device has a self-expanding nitinol frame to secure it in the LAA. The fabric of the WATCHMAN device is permeable to blood. | Device | WATCHMAN |
Primary outcome
Effect of LAA occlusion by LARIAT device
Time frame: Change from Day 0 to Day 90
This registry will provide data on patient outcomes at different times during follow up. This includes: changes in the appendage size, shape and patients medical history.
Effect of LAA occlusion by LARIAT device
Time frame: Change from Day 0 to 356 post-procedure
This registry will provide data on patient outcomes at different times during follow up.This includes: changes in the appendage size, shape and patients medical history.
1 secondary outcome
Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities
Time frame: Days 0, 90, 180, 365 post-procedure and annually thereafter
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 2 May 2019.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
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.
Dhanunjaya Lakkireddy, MD principal investigator
University of Kansas Medical Center
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, run by Kansas City Heart Rhythm Institute 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 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: finished, as of the sponsor's last update on 2 May 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?
Effect of LAA occlusion by LARIAT device (time frame: Change from Day 0 to Day 90). The study lists 2 primary outcomes in all. 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 2 May 2019.