Atrial Fibrillation Clinical Trial
Official title:
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects
an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure,
and premature death. For those with AF and other stroke risk factors, chronic
anticoagulation is recommended to prevent intracardiac thrombus formation and stroke even if
the AF is infrequent or short-lived. This standard of care is based partly on our inability
to rapidly recognize and respond to AF recurrences which can often be brief and
asymptomatic, but exposes the patient to the risk of anticoagulant-induced hemorrhage even
during prolonged periods of sinus rhythm where the risk of stroke is presumably low.
Recent advances in device technology and drug therapy, however, have the potential to change
the way the investigators manage AF. The use of a small leadless subcutaneous implantable
cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.)
provides the ability to remotely and continuously evaluate a patient for AF recurrences,
even episodes that are brief and asymptomatic. In addition, release of unique oral thrombin
inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto])
allows for rapid onset anticoagulation within minutes to hours of a single oral dose.
Together, these advances allow for continuous AF monitoring with targeted anticoagulation
only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage
while still protecting against stroke.
The aim of this pilot study is to assess the feasibility of intermittent anticoagulation
with a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable
cardiac monitor (Reveal XT) with remote data transmission capabilities.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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