Atrial FibrillationNCT01118299
AMPLATZER Cardiac Plug Clinical Trial
A study testing AMPLATZER Cardiac Plug in people with Atrial Fibrillation and Ischemic Stroke, run by Abbott Medical Devices at 18 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism
- What is being tested?
- AMPLATZER Cardiac Plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 18 sitesUnited States
- Study dates
- 26 Apr 2010to 6 Dec 2018
- Phase
- Interventional
- 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 must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
- Subject must be ≥18 years of age
- Subject must be on warfarin or dabigatran therapy
- Subject must be eligible for long term warfarin or dabigatran therapy
- Subject must have a CHADS(2) score of 2 or greater
- Summary of Exclusion Criteria:
Show all 19Show fewer
- Subject who requires warfarin or dabigatran for a condition other than AF
- Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
- Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
- Subject with a New York Heart Association (NYHA) classification equal to IV
- Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- Subject with aortic or mitral valve regurgitation of grade 2+ or greater
- Subject with left ventricular ejection fraction (LVEF) ≤30
- Subject with mitral or aortic prosthetic valve
- Subject with a history of hemorrhagic or aneurysmal stroke
- Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
- Subject with a body mass index (BMI) ≥40
- Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
- Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory Midtown Hospital and Emory University Hospital
Atlanta, Georgia, 30308
St. Joseph's Hospital and Research Institute
Atlanta, Georgia
University of Colorado Denver
Aurora, Colorado, 80045
Roper Hospital/PMG Research of Charleston
Charleston, South Carolina, 29401
Henry Ford Hospital
Detroit, Michigan, 48202
Spectrum Health
Grand Rapids, Michigan, 49503
Memorial Hermann Hospital
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Kentucky
Lexington, Kentucky, 40506
South Denver Cardiology Associates
Littleton, Colorado, 80120
Good Samaritan Hospital
Los Angeles, California, 90017
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Cloud Hospital/CentraCare Heart and Vascular Clinic
Saint Cloud, Minnesota, 56303
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
Providence Hospital
Southfield, Michigan, 48075
Aspirus Heart & Vascular Institute
Wausau, Wisconsin, 54401
York Hospital
York, Pennsylvania, 17405
About this study
Official title: Amplatzer Cardiac Plug Clinical Trial
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.
- Being tested
- AMPLATZER Cardiac Plug
- Keywords
- ACP, Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Dabigatran, Pradaxa, Blood thinning medication, Left atrial appendage, LAA
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER Cardiac PlugDevice
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | AMPLATZER Cardiac Plug Receives: Device: AMPLATZER Cardiac Plug |
| Optimal Medical Therapy (control) | Active comparator | Warfarin Dabigatran Receives: Device: AMPLATZER Cardiac Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques.
The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).
However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol.
Measured: From Randomization to Discharge Visit
Long-term Safety - Device Arm Only
All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).
However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Measured: Randomization to 2 year follow-up
Effectiveness Endpoint - Device Arm Only
Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).
However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Measured: Randomization through 2 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 posted6 May 2010 (estimated)
- Study start26 Apr 2010
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
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.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118299
- Sponsor's protocol ID
- CL00921
- Status last verified
- Apr 2020
- First submitted
- 5 May 2010
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplatzer Cardiac Plug Clinical Trial
- ClinicalTrials.gov ID
- NCT01118299
- Acronym / sponsor ID
- CL00921
- Keywords
- ACP, Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Dabigatran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2010 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: AMPLATZER Cardiac PlugAMPLATZER Cardiac Plug |
| Optimal Medical Therapy (control) | Active comparator | Device: AMPLATZER Cardiac PlugWarfarin Dabigatran |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
- Subject must be ≥18 years of age
- Subject must be on warfarin or dabigatran therapy
- Subject must be eligible for long term warfarin or dabigatran therapy
- Subject must have a CHADS(2) score of 2 or greater
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AMPLATZER Cardiac PlugAMPLATZER Cardiac Plug is a percutaneous transcatheter device | Device | Device, Optimal Medical Therapy (control) |
Primary outcome
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
Time frame: From Randomization to Discharge Visit
An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol.
Long-term Safety - Device Arm Only
Time frame: Randomization to 2 year follow-up
All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Effectiveness Endpoint - Device Arm Only
Time frame: Randomization through 2 year follow up
Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- What is Atrial Fibrillation - Fact SheetLink provided by the sponsor.
- Overview of Atrial FibrillationLink provided by the sponsor.
- Let's Talk about Stroke, TIA and Warning Signs - Fact SheetLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLATZER Cardiac Plug in people with Atrial Fibrillation and Ischemic Stroke, run by Abbott Medical Devices at 18 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 19 inclusion and 0 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 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). 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?
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only (time frame: From Randomization to Discharge Visit). The study lists 3 primary outcomes in all. 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 14 Apr 2020.