AMPLATZER Cardiac Plug Clinical Trial
Amplatzer Cardiac Plug Clinical Trial
1 other identifier
interventional
97
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Apr 2010
Longer than P75 for not_applicable atrial-fibrillation
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2018
CompletedResults Posted
Study results publicly available
April 14, 2020
CompletedApril 14, 2020
April 1, 2020
8.6 years
May 5, 2010
November 19, 2019
April 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Randomization through 2 year follow up
Study Arms (2)
Device
EXPERIMENTALAMPLATZER Cardiac Plug
Optimal Medical Therapy (control)
ACTIVE COMPARATORWarfarin Dabigatran
Interventions
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Good Samaritan Hospital
Los Angeles, California, 90017, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
Emory Midtown Hospital and Emory University Hospital
Atlanta, Georgia, 30308, United States
St. Joseph's Hospital and Research Institute
Atlanta, Georgia, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Providence Hospital
Southfield, Michigan, 48075, United States
St. Cloud Hospital/CentraCare Heart and Vascular Clinic
Saint Cloud, Minnesota, 56303, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
York Hospital
York, Pennsylvania, 17405, United States
Roper Hospital/PMG Research of Charleston
Charleston, South Carolina, 29401, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Aspirus Heart & Vascular Institute
Wausau, Wisconsin, 54401, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sripad Bellary
- Organization
- Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 6, 2010
Study Start
April 26, 2010
Primary Completion
December 6, 2018
Study Completion
December 6, 2018
Last Updated
April 14, 2020
Results First Posted
April 14, 2020
Record last verified: 2020-04