Left Atrial Appendage OcclusionPhase 2NCT00841529
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
A Phase 2 study testing Medtronic LAA Occlusion Device in people with Left Atrial Appendage Occlusion, run by Medtronic Cardiovascular at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Atrial Appendage Occlusion
- What is being tested?
- Medtronic LAA Occlusion Device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2009to Jun 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 to 80 years
- 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 and less than or equal to 80 years of age
- Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
- The subject is willing and able to provide written informed consent and comply with study requirements
- The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)
Who cannot join
- Thrombus in the LAA and/or left atrium
- Prior LAA isolation attempts
- Subject is unable to take an anticoagulant during the study follow-up period
- Subject is undergoing an emergency cardiac procedure
- Life expectancy of less than 12 months
- Pregnancy or desire to be pregnant within the 12 months of the study procedure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Yale University School of Medicine
New Haven, Connecticut, 06510
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Eisenhower Medical Center
Rancho Mirage, California, 92270
About this study
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
- Conditions
- Left Atrial Appendage Occlusion
- Being tested
- Medtronic LAA Occlusion Device
- Keywords
- left atrial appendage, LAA, atrial fibrillation, AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic LAA Occlusion DeviceDevice
Also called Medtronic Cardioblate Closure Left Atrial Appendage Occlusion Device
Placement of the occlusion band on the LAA
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete occlusion of the left atrial appendage
Measured: 3 Months
Secondary outcomes (1)
To evaluate the composite incidence rate of device-related adverse events
Measured: Discharge/30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionJun 2010
Why it stopped: Medtronic Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage OcclusionStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick McCarthy, MD, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841529
- Sponsor's protocol ID
- D02940
- Status last verified
- Oct 2012
- First submitted
- 10 Feb 2009
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
- ClinicalTrials.gov ID
- NCT00841529
- Acronym / sponsor ID
- D02940
- Conditions
- Left Atrial Appendage Occlusion
- Keywords
- left atrial appendage, LAA, atrial fibrillation, AF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medtronic Business Decision
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Feb 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 purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
- Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
- The subject is willing and able to provide written informed consent and comply with study requirements
- The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)
Key exclusion criteria (6 listed)
- Thrombus in the LAA and/or left atrium
- Prior LAA isolation attempts
- Subject is unable to take an anticoagulant during the study follow-up period
- Subject is undergoing an emergency cardiac procedure
- Life expectancy of less than 12 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 |
|---|---|---|
| Medtronic LAA Occlusion DeviceAlso: Medtronic Cardioblate Closure Left Atrial Appendage Occlusion DevicePlacement of the occlusion band on the LAA | Device | – |
Primary outcome
Complete occlusion of the left atrial appendage
Time frame: 3 Months
1 secondary outcome
To evaluate the composite incidence rate of device-related adverse events
Time frame: Discharge/30 days
Results and safety
The study was stopped early (reason given: Medtronic Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
Related trials for Left Atrial Appendage Occlusion
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Recruiting
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Atrial Fibrillation (AF), Paroxysmal AF
RecruitingPhase 4
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Atrial Fibrillation, Left Atrial Appendage Absent
Recruiting
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
Atrial Fibrillation (AF)
Recruiting
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Coronary Artery Disease
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.
Patrick McCarthy, MD study chair
Northwestern University
5 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 Medtronic LAA Occlusion Device in people with Left Atrial Appendage Occlusion, run by Medtronic Cardiovascular at 5 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: Medtronic Business Decision). Results are not available in the source record.
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?
Complete occlusion of the left atrial appendage (time frame: 3 Months). 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 23 Oct 2012.