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AMPLATZER Cardiac Plug Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01118299
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ischemic Stroke Peripheral Thromboembolism Device: AMPLATZER Cardiac Plug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Amplatzer Cardiac Plug Clinical Trial
Actual Study Start Date : April 26, 2010
Actual Primary Completion Date : December 6, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device
AMPLATZER Cardiac Plug
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Active Comparator: Optimal Medical Therapy (control)
Warfarin Dabigatran
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118299


Locations
Show Show 18 study locations
Sponsors and Collaborators
Abbott Medical Devices
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Additional Information:
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01118299    
Other Study ID Numbers: CL00921
First Posted: May 6, 2010    Key Record Dates
Results First Posted: April 14, 2020
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Abbott Medical Devices:
ACP
Atrial Fibrillation
AF
A Fib
Stroke
Coumadin
Warfarin
Dabigatran
Pradaxa
Blood thinning medication
Left atrial appendage
LAA
Additional relevant MeSH terms:
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Atrial Fibrillation
Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis