CompletedPhase 4

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

United States101 participantsStarted 2013-10

Plain-language summary

The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency ablation, or cryoablation procedures.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female sex, age 18-85 years. * Negative pregnancy test for women of childbearing potential * Planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF), or left atrial flutter following prior left atrial ablation procedures * CHADS2 score of 0-6 or CHADS2-VASc score 0-9 * Vascular hemostasis within 4-6 hours of sheath pull * Able to give informed consent Exclusion Criteria: * Unable to give informed consent * Currently participating in another clinical treatment trial * History of hereditary hemophilias * Presence of active bleeding * End stage renal disease, CrCl\<15 mL/min * Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran) * Known allergic reaction to dabigatran etexilate * Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI. * Pregnancy * History of non-compliance * Inability to follow-up

What they're measuring

Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.

Timeframe: Within 4 months following procedure (+/- 4 days)

Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.

Timeframe: Within 4 months following procedure (+/- 4 days)

Trial details

NCT IDNCT01976507

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2017-08-13

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.

Timeframe: Within 4 months following procedure (+/- 4 days)

Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.

Timeframe: Within 4 months following procedure (+/- 4 days)