Safe Use of New Oral Anticoagulants in Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Safe Use of New Oral Anticoagulants in Patients Treated by Catheter Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569255
• Other study ID #: NOAC and PVI 2015
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: October 2, 2015
• Start date: November 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Private Hospital Heart Center Varde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.

Description:

Use of new oral anticoagulants (NOAC) in patients before and after radiofrequency ablation with pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients paused their NOAC treatment for 24 hours before ablation. Patients were routinely followed up after 3 months with a standard formular focused on possible adverse events (major bleeding complications or thromboembolic events) to NOAC treatment. Adverse events related to the use of NOAC were registered during treatment or during 3 months of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Symptomatic atrial fibrillation despite pharmacological treatment.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary venous ostia isolation
Percutaneous, catheterbased, radiofrequency ablation with left atrial access via atrial septal puncture. Helped by 3D-imaging system (Carto(tm)) and electrical signal guidance the PV ostia together with neighbouring atrial tissue is electrically isolated from the rest of the left atrium.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Private Hospital Heart Center Varde

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with bleeding or thromboembolism during PVI and/or three months of follow up	Any bleeding or thromboembolism observed during the PVI procedure and/or during 3 months of follow-up are registered. Also, if any procedure related complication was worsened by treatment with NOAC was registered.	Up to three months after PVI	No