Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Non-coumadin Oral Anticoagulant
Intervention description: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Intervention MeSH terms: Rivaroxaban; Apixaban; Dabigatran; Anticoagulants
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; reveal xt; oral anticoagulation; dabigatran; rivaroxaban; apixaban

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must meet all of the following criteria:

          1. Age 18 and above.

          2. Patients with non-valvular, non-continuous AF and either:

             (A) Infrequent AF episodes without a rhythm control strategy who have had no
             documented AF lasting > 1 hour for 3 consecutive months (the last 2 of which are on a
             previously implanted Reveal XT implantable cardiac monitor), or (B) Previous or
             current rhythm control strategy. Rhythm control strategies may include: i. Class I or
             Class III antiarrhythmic drugs ii. Pulmonary vein isolation iii. Post-MAZE/minimally
             invasive MAZE

          3. Current Reveal XT implant prior to study enrollment.

          4. Documented clinical history of symptomatic or asymptomatic paroxysmal, long-standing
             persistent or persistent AF prior to rhythm control initiation. The duration of AF
             must have been > 30 seconds as documented by an external monitor, present 12 lead ECG,
             or Reveal XT.

          5. CHADS2 score of 1 or 2

          6. Candidates for chronic anticoagulation with an FDA-approved non-Coumadin oral
             anticoagulant (dabigatran, rivaroxaban, apixaban), based on the discretion of the
             treating physician.

          7. Demonstrated ability to tolerate dabigatran 150mg/BID (if CrCl >30ml/min), rivaroxaban
             15mg QD (if CrCl 15-49 ml/min) and 20mg QD (if CrCl ≥50ml/min), or apixaban 5mg BID or
             2.5 mg for subjects with ≥2 of the following: age ≥ 80 years, body weight ≤60kg, serum
             creatinine ≥1.5 mg/dl.

          8. Able and willing to provide written informed consent and willing to follow
             instructions, attend all required study visits, and undergo all planned tests.

          9. Subject must be willing and able to discontinue oral anticoagulation for the purposes
             of this study

        Exclusion Criteria:

        Patients should not have any of the following criteria:

          1. Permanent AF

          2. Any documented single AF episode lasting ≥ 1 hour per month over two consecutive
             months prior to study enrollment.

             Mechanical prosthetic valves or severe valve disease.

          3. CHADS2 score of 0, or > 2

          4. Subject deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery
             disease) based on discretion of the investigator.

          5. Individual is pregnant, nursing, or planning to become pregnant.

          6. Known hypersensitivity to non-Coumadin oral anticoagulants.

          7. Documented prior stroke or transient ischemic attack.

          8. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated
             hyperthyroidism).

          9. Conditions associated with an increased risk of bleeding:

               -  Major surgery in the previous month

               -  Planned surgery or intervention in the next 3 months.

               -  History of intracranial, intraocular, spinal, retroperitoneal or atraumatic
                  intra-articular bleeding

               -  Gastrointestinal hemorrhage within the past year unless the cause has been
                  permanently eliminated (e.g. by surgery)

               -  Symptomatic or endoscopically documented gastroduodenal ulcer disease in the
                  previous 30 days

               -  Hemorrhagic disorder or bleeding diathesis

               -  Need for anticoagulant treatment for disorders other than AF

               -  Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of
                  enrollment

               -  Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg)

         10. Recent malignancy or radiation therapy (≤6 months)

         11. Anemia (hemoglobin <10g/dL) or thrombocytopenia (platelet count <100K/UL)

         12. Patients who have received an investigational drug in the past 30 days or are
             participating in a drug study.

         13. Intolerance or hypersensitivity to low dose aspirin therapy

         14. Life expectancy less than the expected duration of the trial due to concomitant
             disease.

         15. Any concomitant condition which, in the opinion of the investigator, would not allow
             safe participation in the study (e.g., drug addiction, alcohol abuse).

         16. Inability to comply with daily data transmission requirements.

         17. Known history of isolated atrial flutter/atrial tachycardia without atrial
             fibrillation.

         18. More than 10 false positive atrial fibrillation events lasting > 30 minutes per month
             for two months prior to enrollment on a previously implantable cardiac monitor.

         19. Severe renal impairment (CrCl < 15 ml/min)