Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Thromboembolism; Atrial Flutter
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic
      event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of
      dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency
      ablation, or cryoablation procedures.
    

Detailed description: 
      Study design

      Approximately 100 patients who plan to have pulmonary vein isolation by antral radiofrequency
      or cryoablation for paroxysmal or persistent atrial fibrillation, or left atrial flutter
      following prior left atrial ablation procedures, with CHADS2 score of 0-6 or CHADS2-VASc
      score 0-9 will be eligible for this trial and enrolled. A transesophageal echocardiogram
      (TEE) will be performed pre-procedure based on the presenting cardiac rhythm the day of
      planned catheter ablation, stroke risk by CHADS2 or CHADS2-VASc score, and preceding use of
      therapeutic anti-coagulation (as per current 2012 HRS/ACC/ESC guidelines on atrial
      fibrillation management). Immediately following the ablation procedure (4-6 hours after
      sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily
      based on creatinine clearance in the Use in Specified Populations (USPI), will be
      administered for a minimum of 3 months post RF ablation. This represents the standard
      blanking period for post atrial fibrillation or left atrial flutter catheter ablation
      anticoagulation therapy. After the 3 months blanking period, patients may safely be taken off
      dabigatran in the low risk group for stroke or thromboembolism, according to the
      investigators discretion (CHADS 2 score 0-1, or CHADS2-VASc score 0-1). If on dabigatran
      etexilate pre-procedure, the drug will be held at least 24 hours before the intervention
      depending on renal function of the patient (as per recommendations in the USPI). If possible,
      discontinue dabigatran 1 to 2 days (CrCl >50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before
      an invasive or surgical procedure, due to increased risk of bleeding.

      Dabigatran etexilate will be resumed 4-6 hours after sheath pull and vascular hemostasis post
      ablation as above. Intra-procedure intravenous heparin drip will be started once left atrial
      access is obtained with an ACT goal target 300-350 seconds by weight based nomogram.
      Standardized ablation endpoints (4 vein entrance and exit block with post ablation adenosine
      challenge and/or isoproterenol, or termination of left atrial flutter and completion of
      linear ablation confirmed by differential pacing) will be documented, along with
      radiofrequency or cryoablation

      delivery time, fluoroscopy and total case time. Inpatient adverse events will be documented,
      and outpatient follow up will occur at 1 and 3 months post ablation per standard protocol,
      with documentation of all composite endpoints (see below). In addition, a 30 day post study
      phone call follow up will be performed (30 days +/- 4 days following the 3 month visit).
      Please see Table 1 for the schedule of events.

      Our hypothesis is that exposure to dabigatran in the setting of AF left atrial catheter
      ablation will be associated with alow or acceptable risk of major adverse bleeding risks, and
      low thromboembolic event rates post RF ablation, in accordance with our previous data, and in
      contrary to the findings of Lakireddy, et al, in their retrospective study published 2012 in
      JACC. This could lead to widespread utilization of dabigatran etexilate for centers
      performing a high number of atrial fibrillation and left atrial flutter ablation procedures.
    

Intervention name(s): dabigatran etexilate mesylate
Intervention type(s): Drug
Intervention description(s): Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
Other intervention name(s): Pradaxa
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment