Atrial AppendageNCT02059707
LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS
A study testing LARIAT RS Suture Delivery Device in people with Atrial Appendage, run by AtriCure, Inc. at 1 site in Poland.
Trial summary
The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Appendage
- What is being tested?
- LARIAT RS Suture Delivery Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2014to May 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Diagnosed non-valvular atrial fibrillation
- Current CHADS2 score ≥ 2
- Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)
- Life expectancy of ≥ 1 year
- Willing and able to provide written informed consent
- Willing and able to come to and comply with scheduled follow-up visits
Who cannot join
- Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
- Prosthetic heart valve or ring in any position
- Current NYHA Class IV heart failure symptoms
- Current right heart failure
- Myocardial infarction or unstable angina within last 3 months
- Current cardiogenic shock or hemodynamic instability
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- Current symptomatic carotid disease
- Need for an intra-aortic balloon pump or intravenous inotropes
- Embolic stroke or transient ischemic attack (TIA) within the last 30 days.
- Current diagnosis of active systemic infection
- Need for emergent cardiac surgery (e.g., cardiogenic shock)
- Current renal failure requiring dialysis
- Current clinical evidence of cirrhosis
- Any history of thoracic radiation
- Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
- Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
- Any history of pericarditis
- Pectus excavatum (clinically defined by treating physician)
- Severe scoliosis
- Pregnancy or desire to get pregnant within the next 12 months.
- LVEF < 30%
- Current participation in a clinical investigation that involves an active treatment arm.
- Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
- Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS Suture Delivery Device
The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.
Read the detailed description
Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.
- Conditions
- Atrial Appendage
- Being tested
- LARIAT RS Suture Delivery Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARIAT RS Suture Delivery DeviceDevice
LARIAT RS Suture Delivery Device
| Study group | Role | What they receive |
|---|---|---|
| LAA exclusion procedure | Experimental | LAA exclusion with the LARIAT RS Suture Delivery Device Receives: Device: LARIAT RS Suture Delivery Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects with complete exclusion
To assess the rate of complete exclusion of the LAA measured by color duplex TEE at 4 time points: Acute (i.e., immediately after LAA exclusion procedure), 1 day, 1 month, and 3 month.
Measured: 90 days
Secondary outcomes (1)
Secondary Exploratory objectives of procedural success and device-related complication rates
- The rate of procedural success
- The rate of complications related to the use of the LARIAT RS and accessories
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial AppendageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059707
- Sponsor's protocol ID
- RS-003 V1.0_30Oct2012
- Status last verified
- Mar 2017
- First submitted
- 6 Feb 2014
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS Suture Delivery Device
- ClinicalTrials.gov ID
- NCT02059707
- Acronym / sponsor ID
- RS-003 V1.0_30Oct2012
- Conditions
- Atrial Appendage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Feb 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 objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.
Detailed description
Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAA exclusion procedure | Experimental | Device: LARIAT RS Suture Delivery DeviceLAA exclusion with the LARIAT RS Suture Delivery Device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 21 years
- Diagnosed non-valvular atrial fibrillation
- Current CHADS2 score ≥ 2
- Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)
- Life expectancy of ≥ 1 year
Key exclusion criteria (24 listed)
- Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
- Prosthetic heart valve or ring in any position
- Current NYHA Class IV heart failure symptoms
- Current right heart failure
- Myocardial infarction or unstable angina within last 3 months
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 RS Suture Delivery DeviceLARIAT RS Suture Delivery Device | Device | LAA exclusion procedure |
Primary outcome
Percent of subjects with complete exclusion
Time frame: 90 days
To assess the rate of complete exclusion of the LAA measured by color duplex TEE at 4 time points: Acute (i.e., immediately after LAA exclusion procedure), 1 day, 1 month, and 3 month.
1 secondary outcome
Secondary Exploratory objectives of procedural success and device-related complication rates
Time frame: 3 month
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 9 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARIAT RS Suture Delivery Device in people with Atrial Appendage, run by AtriCure, Inc. at 1 site in Poland.
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 7 inclusion and 24 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 9 Jan 2020. 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 Poland. 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?
Percent of subjects with complete exclusion (time frame: 90 days). 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 9 Jan 2020.