DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation (DAPPARAF)

Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation

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-procedural bleeding and thromboembolic complications.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: dabigatran

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 a minimum of 2 days prior to Dabigatran initiation, when the INR is less than 2. Patients will remain on the same dose of Dabigatran until the day before ablation. On the day prior to ablation, patients will not take any Dabigatran, nor will any be taken on the day of ablation, until after sheath removal.

For patients in high-risk groups for bleeding, the lower dose of Dabigatran may be used, or the drug may be stopped further in advance of the procedure. For patients with age greater than 80 years old, the lower dose of Dabigatran (110 mg BID) may be used as an alternative. For patients with impaired renal function, the lower dose may be used, but the drug may be stopped earlier in advance of the procedure as per the suggestions in Appendix A.

Post-ablation, Dabigatran will be started at the same dose - either 150 mg or 110 mg - as before the ablation procedure. Dabigatran will be initiated 8 hours post sheath removal and continue twice daily until the three month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dabigatran; Dabigatran will be compared to historical data using other OAC methods for Pulmonary Vein Ablation	Drug: dabigatran; 30 days pre ablation and 90 days post ablation; Other Names: pradax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of peri-procedural major bleeding complications	1 month prior to Pulmonary Vein Ablation and three months post ablation.

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Allan Skanes, MD, FRCPC, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2011
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): June 7, 2017

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: PVA; peri procedural bleeding complications
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran
• Other Study ID Numbers: HSREB 18098