Atrial Fibrillation Clinical Trial
Official title:
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism in Patients Undergoing Left Atrial Catheter Ablation Procedures for Paroxysmal or Persistent (Non-permanent) Atrial Fibrillation and Left Atrial Flutter
Verified date | February 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 101 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Boehringer Ingelheim |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of major bleeding complications and thrombo-embolic events in patients administered dabigatran following RF ablation. | Within 4 months following procedure (+/- 4 days) | ||
Secondary | Dabigatran serum drug levels in patients experiencing a major bleeding or thrombo-embolic event. | Within 4 months following procedure (+/- 4 days) | ||
Secondary | Frequency of minor bleeding events | Within 4 months following procedure (+/- 4 days) |
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