Atrial Fibrillation Clinical Trial
Official title:
The Comparative Efficacy of the Zio Patch vs Implantable Loop Recorder in Atrial Fibrillation
The aim of our study is to investigate if LTCM's are superior to implantable loop recorders in detecting atrial fibrillation after pulmonary vein isolation. This study will provide insights on a possible alternative for detection of arrhythmia.
Summary Atrial fibrillation (AF) is the most common arrhythmia, increasing in prevalence
with age characterized by chaotic contraction of the atrium. An estimated 2.2 million people
in the United States and 4.5 million in the European Union have AF.[1,2] AF is associated
with heart failure, hemodynamic impairment, and symptoms affecting quality of life. Patients
have an increased risk of thromboembolic events, including stroke, resulting in significant
morbidity, mortality, and costs. [1-5]
Diagnosis of atrial fibrillation is made via an electrocardiogram (ECG) recording. Any
arrhythmia that has the ECG characteristics of AF and lasts sufficiently long for a 12-lead
ECG to be recorded, or at least 30 seconds on a rhythm strip, should be considered an AF
episode.[6] The diagnosis requires an ECG or rhythm strip demonstrating: 1) "absolutely"
irregular RR intervals (in the absence of complete AV block), 2) Absence of distinct P waves
on the surface ECG, and 3) an atrial cycle length (when visible) that is usually variable
and less than 200 msec. [7]
During the past decade, catheter ablation of atrial fibrillation (AF) has evolved rapidly
from an investigational procedure to its current status as a commonly performed ablation
procedure in many major hospitals throughout the world. The goal of the ablation is to
isolate the pulmonary veins from which in the majority of the population atrial fibrillation
originates. During the past several years a large number of meta analyses have been
performed in the hope of better defining the efficacy of AF ablation. Overall, the success
rate was 77.8% in the ablation arm as compared with 23.3% in the control group.
Catheter ablation has decreased the recurrence of AF by 71% (relative risk 0.29). Several
other meta analyses of randomized clinical trials have confirmed these findings [8-12].
Background and Significance Arrhythmia monitoring in patients undergoing atrial fibrillation
ablation is challenging. Trans-telephonic monitors (TTMs) are cumbersome to use and provide
limited, temporal assessment. Implantable loop recorders may overcome these limitations. The
ABACUS study sought to evaluate the utility of implantable loop recorders (ILRs) versus
conventional monitoring (CM) in patients undergoing AF ablation. In AF ablation patients,
ILR detected more arrhythmias than CM. However, false detection remained a challenge
including the inability to the ILR to detect atrial fibrillation less than 2 minutes in
duration. The investigators concluded that with adequate oversight, ILRs may be useful in
monitoring these patients after ablation. [13] ILR's have been convenient to patients due to
the fact that they do not require electrodes or patches. In addition there is no external
monitor that must be accompanied with the electrode adhesive pair.
Despite the convenience of the ILR with respect to everyday life, there is an offset to
diagnostic sensitivity given inherent algorithms limiting the fastest time to detection 2
minutes. Current Heart Rhythm Consensus 2012 HRS/EHRA/ECAS Expert Consensus Statement on
Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient
Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints,
and Research Trial DesignS consensus demonstrates 30 seconds as deemed clinically acceptable
for duration of atrial fibrillation. Despite advances in technology patients can frequently
experience recurrence of atrial fibrillation either after cardioversion or post atrial
fibrillation ablation.
Implantable loop recorders have emerged as a technology which requires a surgical procedure
and can potentially record continuous rhythm for its battery life which usually lasts
approximately three years. The procedure can also lead to explantation secondary to erosion
or migration. Some cardiologists and electrophysiologists use the ILR post ablation for AF
surveillance. This affords long term surveillance, however the device is costly and there is
a risk of infection as well. Novel technology termed LTCM has the capability to record and
store continuous ECG for up to 14 days.
Novel technology available termed ambulatory long term continuous monitor (LTCM) one of
which includes Zio XT has the capability to record and store continuous ECG for up to 14
days. Long Term Cardiac Telemetry provides beat-to-beat ECG recording, storage and analysis
with automatic arrhythmia detection. The ZIO XT device utilizes an adhesive patch which
attaches conveniently to the patient. The LTCM has the capability to detect AF of duration
less than 2 minutes when compared to the ILR. The patches are disposable and may be worn for
up to 14 days duration. . The Zio patch They contains a proprietary algorithm which can
detect a number of different arrhythmias including but not limited to non-sustained
ventricular tachycardia, brady- arrhythmia including heart block as well as life threatening
polymorphic ventricular tachycardia. LTCMs are substantially cost effective and may be used
in clinics or emergency departments. The LTCMs however have not been studied in a
comparative effectiveness trial with implantable loop recorders.
Each patient will already have an implantable loop recorder and will receive the Zio patch
as the experimental arm of the trial.
The primary endpoint of our investigation is to compare LTCM's verses implantable loop
recorders in successful detection and recurrence of atrial fibrillation after pulmonary vein
isolation. We hypothesize the LTCM's will detect atrial fibrillation after pulmonary vein
isolation more accurately than the implantable loop recorders. Secondary objectives will be
the comparisons of the following:
1. Agreement between the assessment of events between the two devices.
2. Sensitivity, Specificity, PPV, Accuracy and Reliability of each of the two devices of
(LTCM vs. ILR) compared to the ECG readout of each. That is, the ECG from the LCTM will
be used as the gold standard to assess the LCTM events and the ECG from the ILR will be
used to assess the ILR events. Summary statistics from these two events will be
presented side by side.
3. Successful symptom rhythm correlation judged by using a patient activator on the patch
4. Signal Quality in Voltage of ILR vs. LTCM
5. Rate of False Detection in ILR vs. LTCM
6. Quality of Monitoring Experience Survey of the patient
7. Cost Benefit Analysis
7. Economic outcomes 8. Arrhythmia other than AF detected
Research Plan Inclusion Criterion
1. Patients with a diagnosis of paroxysmal or persistent atrial fibrillation documented on
electrocardiography
2. Patients must already have a Medtronic LINQ ILR as standard of care already implanted
as standard of care
3. Patients must be available for at least 7 but maximum of 14 days after patch
application
4. Patients must be greater than or equal to 18 years old.
Exclusion Criterion
Patients less than 18 years of age
1. Patients with a history of permanent atrial fibrillation
2. Patients with an implanted pacemaker or implantable cardioverter defibrillator
3. CPatients with cognitive delay and or dementia
4. UPatients unable to give Consent.
5. Patients with adhesive allergy
Research Design The study will be performed at the University of Florida Health Science
Center at UF Health, Jacksonville-Division of Cardiology. Patients will be recruited in the
Cardiology Clinics of our institution and will be screened by Cardiology Research Staff, who
will verify all candidates meet inclusion and exclusion criteria.
Patients found eligible for this study will already have undergone an implantable loop
recorder (ILR) (Medtronic LINQ, Minneapolis, MN) implant. After providing written informed
consent, subjects will be paired with a LTCM - ZIO® Patch, iRhythm Technologies, Inc. San
Francisco, CA).
Both the ILR and ZIO Patch will be set to Eastern Standard Time (EST). Subjects will be
instructed to wear the ZIO Patch for a minimum of 7 days but not exceeding 14 days.
To help ensure compliance a study follow up phone call will be made at day 7 (+/- 1 day).
Subjects will return to UF Shands -Jacksonville on day 12 (+/- 2 days) for removal of the
patch and data download of ILR. Quality of Monitoring Questionnaire will be provided.
To avoid reporting bias raw data from the ZIO Patch, raw data of the event recording (ECG
analysis)will be reviewed by an adjudication committee of two three board certified
cardiologists. If there is disagreement, a third physician will decide.
At the final study visit (as outlined in METHODS) the patch will be shipped to iRhythm.
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