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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

dabigatran

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring PVA, peri procedural bleeding complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

London Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Dabigatran

Arm Description

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

Outcomes

Primary Outcome Measures

The incidence of peri-procedural major bleeding complications

Secondary Outcome Measures

Full Information

NCT ID

NCT01468155

First Posted

November 7, 2011

Last Updated

November 2, 2017

Sponsor

Lawson Health Research Institute

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01468155

Brief Title

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

Acronym

DAPPARAF

Official Title

Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 13, 2011 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

June 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lawson Health Research Institute

Collaborators

Boehringer Ingelheim

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

PVA, peri procedural bleeding complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

dabigatran

Other Intervention Name(s)

pradax

Intervention Description

30 days pre ablation and 90 days post ablation

Primary Outcome Measure Information:

Title

The incidence of peri-procedural major bleeding complications

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan Skanes, MD, FRCPC

Organizational Affiliation

Lawson Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Sciences Center

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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