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

NCT01468155 | Completed Phase 4 DMC

• 1 other identifier: HSREB 18098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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-procedural bleeding and thromboembolic complications.

Conditions

Atrial Fibrillation

Keywords

PVA; peri procedural bleeding complications

Outcome Measures

Primary Outcomes (1)

• The incidence of peri-procedural major bleeding complications

  1 month prior to Pulmonary Vein Ablation and three months post ablation.

Study Arms (1)

Dabigatran

ACTIVE COMPARATOR

Dabigatran will be compared to historical data using other OAC methods for Pulmonary Vein Ablation

Drug: dabigatran

Interventions

dabigatran DRUG

30 days pre ablation and 90 days post ablation

Also known as: pradax

Dabigatran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Allan Skanes, MD, FRCPC

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: July 13, 2011
• Primary Completion: January 1, 2017
• Study Completion: June 7, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CA (1)