Status:
COMPLETED
DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
It is hypothesized that peri-ablation Dabigatran will be a safe and effective method of peri-procedural anticoagulation for Atrial Fibrillation (AF) ablation, resulting in a low rate of peri-procedura...
Detailed Description
All patients will be initiated on fixed dose Dabigatran 150 mg BID at least one month prior to the ablation procedure. If patients were already on warfarin therapy, then warfarin should be stopped for...
Eligibility Criteria
Inclusion
- Patients age 18 or greater.
- Patients undergoing first-time catheter ablation for AF.
- Patients with paroxysmal or persistent AF. Paroxysmal AF will be defined as self-terminating episodes less than 7 days duration. Persistent AF will be defined as episodes that last longer than 7 days duration or episodes requiring termination by electrical or chemical cardioversion.
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years prior to enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
- At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of entry in the trial.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Exclusion
- Patients with AF felt to be secondary to an obvious reversible cause (e.g. thyroid disease, post-surgical).
- Patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor.
- Patients with severe renal impairment (creatinine clearance of \<30 ml/min)
- Patients with left atrial size \>/= 60 mm (2D echocardiography, parasternal long axis view).
- Patients who are or may potentially be pregnant or who are not on an effective method of birth control or who are planning to get pregnant during the study.
- Patients with mechanical heart valves.
- Patients who are undergoing repeat catheter ablation of AF.
- Patients with hemorrhagic manifestations, bleeding diathesis, or patients with impairment of hemostasis.
- Lesions at risk of clinically significant bleeding - such as extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding.
- Concomitant treatment with strong P-glycoprotein inhibitors, i.e. ketoconazole.
- Known hypersensitivity to Dabigatran or Dabigatran etexilate.
Key Trial Info
Start Date :
July 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01468155
Start Date
July 13 2011
End Date
June 7 2017
Last Update
November 6 2017
Active Locations (1)
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1
London Health Sciences Center
London, Ontario, Canada, N6A 5A5