N/A
N=97
AMPLATZER Cardiac Plug Clinical Trial
Atrial Fibrillation · Ischemic Stroke · Peripheral Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT01118299 ↗Enrolled (actual)
97
Serious AEs
69.1%
Results posted
Apr 2020
Primary outcome: Primary: Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only — 3; 1; 1; 3 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AMPLATZER Cardiac Plug (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only |
3; 1; 1; 3; 1; 1 | — |
| PRIMARY Long-term Safety - Device Arm Only |
1; 1; 1; 1; 2; 1 | — |
| PRIMARY Effectiveness Endpoint - Device Arm Only |
2; 0 | — |
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 endpoint.
Eligibility Criteria
Inclusion Criteria
- 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:
- 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
Data sourced from ClinicalTrials.gov (NCT01118299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.