An interventional study of AMPLATZER Cardiac Plug in Atrial Fibrillation, Ischemic Stroke and Peripheral Thromboembolism, sponsored by Abbott Medical Devices. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Prevention
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 97 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Summary of Exclusion Criteria:
AMPLATZER Cardiac Plug
Device: AMPLATZER Cardiac Plug
Warfarin Dabigatran
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
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.
Time frame: 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.
Time frame: 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.
Time frame: Randomization through 2 year follow up
| Milestone | Device | Optimal Medical Therapy (Control) |
|---|---|---|
| Started | 68 | 29 |
| Completed | 45 | 0 |
| Not completed | 23 | 29 |
| Withdrew: Death | 7 | 5 |
| Withdrew: Withdrawal by subject | 8 | 8 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Enrollment closure, protocol amendment | 6 | 15 |
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.
| events | Device Arm |
|---|---|
| Device Embolization | 3 |
| Pleural Effusion | 1 |
| Hematoma | 1 |
| Pericardial Tamponade | 3 |
| Cardiac Perforation* | 1 |
| Pericardial Effusion | 1 |
| Cardiogenic Shock* | 1 |
| Pericarditis* | 1 |
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.
| Events | Device Arm |
|---|---|
| Empyema (Major Bleeding) | 1 |
| Hemothorax (Major Bleeding) | 1 |
| Hematoma (Major Bleeidng) | 1 |
| Bleeding (Major Bleeding) | 1 |
| Respiratory Failure (Death) | 2 |
| Congestive Heart Failure (Death) | 1 |
| Device Embolization (Death) | 1 |
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.
| events | Device Arm |
|---|---|
| Ischemic Stroke | 2 |
| Peripheral Thromboembolism | 0 |
Collected over 5 Years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device | 7/68 (10.3%) | 52/68 (76.5%) | 61/68 (89.7%) |
| Optimal Medical Therapy (Control) | 5/29 (17.2%) | 15/29 (51.7%) | 15/29 (51.7%) |
| Event | Device | Optimal Medical Therapy (Control) |
|---|---|---|
| Congestive Heart FailureCardiac disorders | 5/68 | 6/29 |
| Atrial FibrillationCardiac disorders | 8/68 | 1/29 |
| Pericardial EffusionCardiac disorders | 5/68 | 0/29 |
| Atrial TachycardiaCardiac disorders | 0/68 | 2/29 |
| Elective SurgeryCardiac disorders | 1/68 | 2/29 |
| Ischemic StrokeCardiac disorders | 2/68 | 2/29 |
| PneumoniaCardiac disorders | 4/68 | 2/29 |
| SepsisCardiac disorders | 3/68 | 2/29 |
| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)Cardiac disorders | 2/68 | 2/29 |
| Chest PainCardiac disorders | 4/68 | 0/29 |
| Event | Device | Optimal Medical Therapy (Control) |
|---|---|---|
| VASC BleedingCardiac disorders | 10/68 | 0/29 |
| EdemaCardiac disorders | 9/68 | 2/29 |
| HypotensionCardiac disorders | 8/68 | 0/29 |
| PneumoniaCardiac disorders | 3/68 | 3/29 |
| DyspneaCardiac disorders | 7/68 | 1/29 |
| Residual Interatrial CommunicationCardiac disorders | 7/68 | 0/29 |
| VASC HematomaCardiac disorders | 7/68 | 0/29 |
| Atrial FibrillationCardiac disorders | 6/68 | 1/29 |
| FallCardiac disorders | 6/68 | 2/29 |
| Urinary Tract InfectionsCardiac disorders | 6/68 | 1/29 |
All 97 randomized subjects were part of the baseline population.
| Age, Continuous(Years) | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Mean | 74.0 ± 8.5 | 73.4 ± 10.0 | 73.5 ± 8.9 |
| Sex: Female, Male(Participants) | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Female | 23 | 11 | 34 |
| Male | 45 | 18 | 63 |
| Race and Ethnicity Not Collected(Participants) | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| CHADS2 Score(Participants) | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Chads2 Score 0 | 0 | 0 | 0 |
| Chads2 Score 1 | 0 | 0 | 0 |
| Chads2 Score 2 | 38 | 17 | 55 |
| Chads2 Score 3 | 20 | 7 | 27 |
| Chads2 Score 4 | 7 | 4 | 11 |
| Chads2 Score 5 | 2 | 1 | 3 |
| Chads2 Score 6 | 1 | 0 | 1 |
| History of Atrial Fibrillation(Participants) | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Paroxysmal | 32 | 19 | 51 |
| Persistent | 21 | 7 | 28 |
| Permanent | 15 | 3 | 18 |
| Rhythm Status at Baseline(Participants) | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Paced Rhythm | 17 | 15 | 32 |
| Atrial Fibrillation | 29 | 5 | 34 |
| Sinus Rhythm | 19 | 7 | 26 |
| Other Arrhythmias or Conduction Disturbance | 2 | 2 | 4 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.