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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Ontario
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London、Ontario、加拿大、N6A 5A5
- London Health Sciences Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Dabigatran
Dabigatran will be compared to historical data using other OAC methods for Pulmonary Vein Ablation
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30 days pre ablation and 90 days post ablation
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The incidence of peri-procedural major bleeding complications
大体时间:1 month prior to Pulmonary Vein Ablation and three months post ablation.
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1 month prior to Pulmonary Vein Ablation and three months post ablation.
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合作者和调查者
调查人员
- 首席研究员:Allan Skanes, MD, FRCPC、Lawson Health Research Institute
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.