StrokePhase 2NCT00962702
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
A Phase 2 study testing LAAx TigerPaw System in people with Stroke, run by LAAx, Inc. at 1 site in United States.
Trial summary
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- LAAx TigerPaw System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2010
- Phase
- Phase 2
- 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
- Greater than or equal to 18 years of age
- Stroke Risk (CHADS score > or = 2, CHADS scoring: CHF = 1 pt, Hypertension (or treated hypertension) = 1 pt, Age > 75 = 1 pt, Diabetes = 1 pt, Prior stroke or TIA = 2 pts)
- Subject scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following:
- mitral valve repair or replacement
- aortic valve repair or replacement
- tricuspid valve repair or replacement
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- coronary artery bypass procedures
- concomitant surgical (ablation or cut and sew) Maze procedure
- Ejection fraction > 30%
- Absence of thrombus in LAA
- During open procedure, LAA anatomy is determined to be suitable for closure
- life expectancy of > 1 year
- patient willingness to cooperate with follow-up tests
- Informed Consent
Who cannot join
- Previous cardiac surgery
- Contraindication to Transesophageal Echocardiography (TEE)
- Thrombus in the LAA/LA
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (e.g., cardiogenic shock)
- Creatinine > 200 umol/L
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- Current diagnosis of active systemic infection
- Renal failure requiring dialysis or hepatic failure
- A known drug and/or alcohol addiction
- mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study and to cooperate with follow-up requirements
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Treatment with thoracic radiation
- Concurrent chemotherapy
- Long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases
- Known connective tissue disorders
- Coagulation disorders
- Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk
- Active participation in another clinical trial.
- Intraoperative:
- LAA is not appropriate for exclusion based upon intraoperative evaluations
- Presence of thrombus in LAA or LA; or
- Any other findings by surgeon/investigator that would preclude use of device
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clarian Health / Methodist Hospital
Indianapolis, Indiana
Arthur Coffee, MD
About this study
Official title: Exclusion of the Left Atrial Appendage With the LAAx, Inc., TigerPaw™ System During Elective, Non-Endoscopic Cardiac Surgery Procedures
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Read the detailed description
The primary safety outcome is the rate of device related adverse and serious adverse events assessed peri-operatively, and at 30 and 90 days post procedure. The primary effectiveness outcome is the percentage of patients with complete exclusion of the left atrial appendage assessed peri-operatively (visually), and at 90 days post procedure via transesophageal echocardiography (TEE).
Transesophageal echocardiography will be performed intra-operatively and again at 90 days post procedure. Intra-operative and follow-up TEE examinations will be read centrally at a core laboratory. Any Doppler flow across the Fastener into the excluded portion of the appendage will also be considered a failure of exclusion. The presence or absence of LAA and/or LA thrombus will be evaluated. Patients will also be evaluated for other potential sources of embolism, including aortic atheroma, patent foramen ovale, or other intracardiac shunts.
Data collection will be completed at baseline, at the time of open cardiac surgery procedure and throughout the perioperative hospitalization. Patients will be evaluated at 30 days post surgery and at 90 days post surgery.
- Conditions
- Stroke
- Being tested
- LAAx TigerPaw System
- Keywords
- Exclusion, Left Atrial Appendage, Surgical, Open chest
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAx TigerPaw SystemDevice
Exclusion of Left Atrial Appendage
| Study group | Role | What they receive |
|---|---|---|
| Exclusion of Left Atrial Appendage | Experimental | Exclusion of Left Atrial Appendage Receives: Device: LAAx TigerPaw System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dual primary safety and effectiveness outcomes include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Measured: Patients will be evaluated at 30 days post surgery and at 90 days post surgery.
Secondary outcomes (1)
The extent of complete exclusion of the LAA with minimal residual cavity.
Measured: 30 days post surgery and at 90 days post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LAAx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Slaughter, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962702
- Sponsor's protocol ID
- LAAx1DD20809
- Status last verified
- Aug 2009
- First submitted
- 19 Aug 2009
- Last updated
- 20 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusion of the Left Atrial Appendage With the LAAx, Inc., TigerPaw™ System During Elective, Non-Endoscopic Cardiac Surgery Procedures
- ClinicalTrials.gov ID
- NCT00962702
- Acronym / sponsor ID
- LAAx1DD20809
- Conditions
- Stroke
- Keywords
- Exclusion, Left Atrial Appendage, Surgical, Open chest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LAAx, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 20 Aug 2009 (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 dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Detailed description
The primary safety outcome is the rate of device related adverse and serious adverse events assessed peri-operatively, and at 30 and 90 days post procedure. The primary effectiveness outcome is the percentage of patients with complete exclusion of the left atrial appendage assessed peri-operatively (visually), and at 90 days post procedure via transesophageal echocardiography (TEE).
Transesophageal echocardiography will be performed intra-operatively and again at 90 days post procedure. Intra-operative and follow-up TEE examinations will be read centrally at a core laboratory. Any Doppler flow across the Fastener into the excluded portion of the appendage will also be considered a failure of exclusion. The presence or absence of LAA and/or LA thrombus will be evaluated. Patients will also be evaluated for other potential sources of embolism, including aortic atheroma, patent foramen ovale, or other intracardiac shunts.
Data collection will be completed at baseline, at the time of open cardiac surgery procedure and throughout the perioperative hospitalization. Patients will be evaluated at 30 days post surgery and at 90 days post surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exclusion of Left Atrial Appendage | Experimental | Device: LAAx TigerPaw SystemExclusion of Left Atrial Appendage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Greater than or equal to 18 years of age
- Stroke Risk (CHADS score > or = 2, CHADS scoring: CHF = 1 pt, Hypertension (or treated hypertension) = 1 pt, Age > 75 = 1 pt, Diabetes = 1 pt, Prior stroke or TIA = 2 pts)
- Subject scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following:
- Ejection fraction > 30%
- Absence of thrombus in LAA
Key exclusion criteria (22 listed)
- Previous cardiac surgery
- Contraindication to Transesophageal Echocardiography (TEE)
- Thrombus in the LAA/LA
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (e.g., cardiogenic shock)
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 |
|---|---|---|
| LAAx TigerPaw SystemExclusion of Left Atrial Appendage | Device | Exclusion of Left Atrial Appendage |
Primary outcome
The dual primary safety and effectiveness outcomes include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Time frame: Patients will be evaluated at 30 days post surgery and at 90 days post surgery.
1 secondary outcome
The extent of complete exclusion of the LAA with minimal residual cavity.
Time frame: 30 days post surgery and at 90 days post
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2009.
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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.
Mark Slaughter, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAAx TigerPaw System in people with Stroke, run by LAAx, Inc. 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 14 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 20 Aug 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Daniel, MS/ MBA (4154070223, madaniel@clinregconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dual primary safety and effectiveness outcomes include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity. (time frame: Patients will be evaluated at 30 days post surgery and at 90 days post surgery.). 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 20 Aug 2009.