Atrial AppendagePLACE IINCT01983605
Left Atrial Appendage Exclusion Study
A study testing LARIAT Suture Delivery Device in people with Atrial Appendage, run by AtriCure, Inc. at 1 site in Poland.
Trial summary
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Appendage
- What is being tested?
- LARIAT Suture Delivery Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2009to Dec 2013
- 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
- Subject is greater than or equal to 18 years of age
- Subject has atrial fibrillation (paroxysmal or persistent)
- Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
- Subject is willing and able to provide written informed consent
- Subject has a life expectancy of at least 1 year
- Subject is willing and able to return for scheduled follow up visits
Who cannot join
- Previous cardiac surgery
- Thrombus in the left atrial appendage or left atrium
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- LAA is not appropriate for exclusion based upon intraoperative evaluations
- Current diagnosis of active systemic infection
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- Renal failure requiring dialysis or hepatic failure
- A known drug and/or alcohol addiction
- Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study
- Pregnancy or desire to get pregnant within 12 months of the study treatment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Patients who have been treated with thoracic radiation
- Patients in current chemotherapy
- Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
- Patients with known connective tissue disorders, i.e. Lupus
- Previous history of pericarditis
- Presence of a PFO/ASD or valve implant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Atrial Appendage Exclusion Study II
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.
Read the detailed description
The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.
- Conditions
- Atrial Appendage
- Being tested
- LARIAT Suture Delivery Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARIAT Suture Delivery DeviceDevice
LAA exclusion procedure
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | LAA exclusion with the LARIAT Suture Delivery Device Receives: Device: LARIAT Suture Delivery Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device related serious adverse events
Measured: 30 days
Percent of patients with complete exclusion of the LAA measured with TEE
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerzy Sadowski, M.D., Ph.D, Principal investigator, Jagiellonian University (John Paul II) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983605
- Sponsor's protocol ID
- RS-001 V3.0_120709
- Acronym
- PLACE II
- Status last verified
- Oct 2016
- First submitted
- 7 Nov 2013
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013 Jul 9;62(2):108-118. doi: 10.1016/j.jacc.2012.06.046. Epub 2012 Oct 10.
PubMed 23062528
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
- Left Atrial Appendage Exclusion Study II
- ClinicalTrials.gov ID
- NCT01983605
- Acronym / sponsor ID
- PLACE II / RS-001 V3.0_120709
- Conditions
- Atrial Appendage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Nov 2013 (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.
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.
Detailed description
The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: LARIAT Suture Delivery DeviceLAA exclusion with the LARIAT Suture Delivery Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is greater than or equal to 18 years of age
- Subject has atrial fibrillation (paroxysmal or persistent)
- Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
- Subject is willing and able to provide written informed consent
- Subject has a life expectancy of at least 1 year
Key exclusion criteria (17 listed)
- Previous cardiac surgery
- Thrombus in the left atrial appendage or left atrium
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- LAA is not appropriate for exclusion based upon intraoperative evaluations
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 Suture Delivery DeviceLAA exclusion procedure | Device | Treatment |
Primary outcome
Rate of device related serious adverse events
Time frame: 30 days
Percent of patients with complete exclusion of the LAA measured with TEE
Time frame: 90 days
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.
- Results publication: PubMed 23062528Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013 Jul 9;62(2):108-118. doi: 10.1016/j.jacc.2012.06.046. Epub 2012 Oct 10.
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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.
Jerzy Sadowski, M.D., Ph.D principal investigator
Jagiellonian University (John Paul II) Hospital
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 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 6 inclusion and 17 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?
Rate of device related serious adverse events (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT01983605, which also lists 1 linked publication.
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.