Atrial FibrillationPhase 4PLACE IIINCT01680757
Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III
A Phase 4 study testing LARIAT Suture Delivery Device and Accessories in people with Atrial Fibrillation, run by University of California, San Francisco at 12 sites in 3 countries.
Trial summary
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LARIAT Suture Delivery Device and Accessories
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Sep 2012to Mar 2014
- Phase
- Phase 4
- 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
- Aged ≥ 21 years
- Diagnosed non-valvular atrial fibrillation
- Current CHADS2 score > 2
- Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results "out of therapeutic range" > 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).
- Life expectancy of at least 1 year
- Willing and able to return and comply with scheduled follow up visits
- Willing and able to provide written informed consent
Who cannot join
- Prior 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 within last 3 months
- Unstable angina within last 3 months
Show all 28Show fewer
- Current cardiogenic shock or hemodynamic instability
- Current symptomatic carotid disease
- Need for an intra-aortic balloon pump or intravenous inotropes
- Embolic stroke within the last 30 days
- Transient ischemic attack (TIA) within the last 30 days
- Current diagnosis of active systemic infection
- eGFR < 60 mL/min/1.73m2 within last 3 months
- Current renal failure requiring dialysis
- ALT or AST level > 3 times upper level of normal, indicating hepatic failure. (NOTE: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment)
- 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
- Thrombocytopenia (platelet count < 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment)
- Anemia with hemoglobin concentration of < 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment)
- Pregnancy or desire to get pregnant within next 12 months.
- Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry
- 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
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Texas Heart Institute
Houston, Texas, 77030
The Methodist Hospital Research Institute
Houston, Texas, 77030
University of Kansas Hospital and Medical Center
Kansas City, Kansas, 66160
Baptist Hospital of Miami
Miami, Florida, 33176
Columbia University Medical Center
New York, New York, 10032
Banner Good Samaritan
Phoenix, Arizona, 85006
Scripps Green Hospital and Clinic
San Diego, California, 92037
University of California, San Francisco
San Francisco, California, 94122
Swedish Medical Center
Seattle, Washington, 98122
About this study
Official title: Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.
- Conditions
- Atrial Fibrillation
- Being tested
- LARIAT Suture Delivery Device and Accessories
- Keywords
- Left Atrial Appendage, LARIAT, atrial fibrillation, contraindication to oral anticoagulation therapy
- 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 Suture Delivery Device and AccessoriesDevice
Also called LARIATTM Suture Delivery Device, ENDOCATH Occlusion Balloon, SOFTIPTM Guide Cannula, FINDRWIRZ Guide Wire System
| Study group | Role | What they receive |
|---|---|---|
| LAA exclusion with LARIAT & Accessories | Experimental | Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories Receives: Device: LARIAT Suture Delivery Device and Accessories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete exclusion
To assess the rate of complete exclusion of the left atrial appendage (defined as < 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).
Measured: During 1 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: This study has been withdrawn prior to enrollment
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 University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Sponsor
- Investigators
- Gregory Marcus, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680757
- Sponsor's protocol ID
- RS-001 PLACE III
- Acronym
- PLACE III
- Status last verified
- Feb 2013
- First submitted
- 28 Aug 2012
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)
- ClinicalTrials.gov ID
- NCT01680757
- Acronym / sponsor ID
- PLACE III / RS-001 PLACE III
- Conditions
- Atrial Fibrillation
- Keywords
- Left Atrial Appendage, LARIAT, atrial fibrillation, contraindication to oral anticoagulation therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been withdrawn prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 7 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.
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAA exclusion with LARIAT & Accessories | Experimental | Device: LARIAT Suture Delivery Device and AccessoriesPermanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 21 years
- Diagnosed non-valvular atrial fibrillation
- Current CHADS2 score > 2
- Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results "out of therapeutic range" > 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).
- Life expectancy of at least 1 year
Key exclusion criteria (28 listed)
- Prior 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 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 Suture Delivery Device and AccessoriesAlso: LARIATTM Suture Delivery Device, ENDOCATH Occlusion Balloon, SOFTIPTM Guide Cannula, FINDRWIRZ Guide Wire System | Device | LAA exclusion with LARIAT & Accessories |
Primary outcome
Rate of complete exclusion
Time frame: During 1 year follow-up.
To assess the rate of complete exclusion of the left atrial appendage (defined as < 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).
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 25 Feb 2013.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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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.
Gregory Marcus, MD principal investigator
University of California, San Francisco
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LARIAT Suture Delivery Device and Accessories in people with Atrial Fibrillation, run by University of California, San Francisco at 12 sites in 3 countries.
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 28 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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of complete exclusion (time frame: During 1 year follow-up.). 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 25 Feb 2013.