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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Thromboembolism Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMPLATZER Cardiac Plug

Device

AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2018
Study completion: 2018
First posted: May 6, 2010
Registry last updated: Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed