Left Atrial Appendage ExclusionPhase 2EXCLUDENCT00779857

AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

A Phase 2 study testing AtriCure LAA Exclusion System in people with Left Atrial Appendage Exclusion, run by AtriCure, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Left Atrial Appendage Exclusion
What is being tested?: AtriCure LAA Exclusion System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 7 sitesUnited States
Study dates: Sep 2008to Oct 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 any one of the following risk factors and is thought to benefit from LAA occlusion:
CHADS score > 2
Age > 75 years
Hypertension and age > 65 years
Previous stroke

Show all 11Show fewer

History of atrial fibrillation (any classification)
Subject is 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 placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
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 LAA/LA which cannot be evacuated prior to placement of the Clip.
Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
NYHA Class IV heart failure symptoms
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Creatinine >200 µmol/L

Show all 17Show fewer

LAA is not appropriate for exclusion based on intraoperative evaluations
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
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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of Virginia
Charlottesville, Virginia, 22908
Mount Carmel East Hospital
Columbus, Ohio, 43213
Spectrum Health
Grand Rapids, Michigan, 49506
St. Francis Heart Hospital
Indianapolis, Indiana, 45237
Macon Medical Center
Macon, Georgia, 31201
Baylor Heart Hospital
Plano, Texas, 75093
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery

Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.

Conditions: Left Atrial Appendage Exclusion
Being tested: AtriCure LAA Exclusion System
Keywords: left atrial appendage, laa, atrial fibrillation, afib, af, stroke, tia
Medical subject headings: Atrial Fibrillation, Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtriCure LAA Exclusion SystemDevice
Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System

Study groups in NCT00779857
Study group	Role	What they receive
AtriCure LAA Exclusion System	Experimental	AtriCure LAA Exclusion System Receives: Device: AtriCure LAA Exclusion System

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Device Related Serious Adverse Events
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Measured: Discharge/30 days Post Procedure
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.
Measured: 3 Months Post Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Oct 2011

First posted24 Oct 2008 (estimated)
Study startSep 2008
Primary completionOct 2009
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Left Atrial Appendage ExclusionStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00779857
Sponsor's protocol ID: CP2008-2
Acronym: EXCLUDE
Status last verified: May 2013
First submitted: 23 Oct 2008
Last updated: 4 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ailawadi G, Gerdisch MW, Harvey RL, Hooker RL, Damiano RJ Jr, Salamon T, Mack MJ. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1002-9, 1009.e1. doi: 10.1016/j.jtcvs.2011.07.052. Epub 2011 Sep 8.
PubMed 21906756

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
Atrial Appendage

All Left Atrial Appendage Exclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
ClinicalTrials.gov ID: NCT00779857
Acronym / sponsor ID: EXCLUDE / CP2008-2
Conditions: Left Atrial Appendage Exclusion
Keywords: left atrial appendage, laa, atrial fibrillation, afib, af, stroke, tia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: AtriCure, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2011 (actual)
First posted: 24 Oct 2008 (estimated)
Results: Posted 4 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AtriCure LAA Exclusion System	Experimental	Device: AtriCure LAA Exclusion SystemAtriCure LAA Exclusion System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Subject is greater than or equal to 18 years of age.
Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:
Subject is 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 placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
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 LAA/LA which cannot be evacuated prior to placement of the Clip.
Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
NYHA Class IV heart failure symptoms
Need for emergent cardiac surgery (i.e. 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
AtriCure LAA Exclusion SystemExclusion of the left atrial appendage using the AtriCure LAA Exclusion System	Device	AtriCure LAA Exclusion System

Primary outcome

Rate of Device Related Serious Adverse Events
Time frame: Discharge/30 days Post Procedure
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
Time frame: 3 Months Post Procedure
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.

Results and safety

Results posted to the registry on 4 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AtriCure LAA Exclusion System	70	64

Primary outcome: Rate of Device Related Serious Adverse Events

Time frame: Discharge/30 days Post Procedure. Number (95% Confidence Interval). Unit: Number of participants

Measure	AtriCure LAA Exclusion System n = 70
Value	0 (0.00 to 0.0001)

Population analysed: The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.

Primary outcome: Percent of Patients With Complete Occlusion of the Left Atrial Appendage.

Time frame: 3 Months Post Procedure. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	AtriCure LAA Exclusion System n = 61
Value	95.1 (88 to 100)

Population analysed: The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.

Adverse events

Time frame: Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AtriCure LAA Exclusion System	35 of 70 (50%)	63 of 70 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21906756Ailawadi G, Gerdisch MW, Harvey RL, Hooker RL, Damiano RJ Jr, Salamon T, Mack MJ. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1002-9, 1009.e1. doi: 10.1016/j.jtcvs.2011.07.052. Epub 2011 Sep 8.

Related trials for Left Atrial Appendage Exclusion

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Active, not recruiting
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CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
Atrial Appendage

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.

Michael Mack, MD principal investigator

Baylor Heart Hospital

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AtriCure LAA Exclusion System in people with Left Atrial Appendage Exclusion, run by AtriCure, Inc. at 7 sites 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 11 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Yes. Results are posted in the registry (first posted 4 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Discharge/30 days Post Procedure). 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 NCT00779857, 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 4 Jun 2013.