NCT02569255

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

3.1 years

First QC Date

October 1, 2015

Last Update Submit

October 2, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Pulmonary venous ostia isolationPROCEDURE

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.

Also known as: catheter ablation, PVI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with paroxysmal or persistent atrial fibrillation and symptomatic despite pharmacological treatment.

You may qualify if:

  • Symptomatic atrial fibrillation despite pharmacological treatment.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Peter S Hansen, M.D.

    Varde Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Electrophysiologist, MD, Ph.D., DMSci

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 6, 2015

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

October 6, 2015

Record last verified: 2015-10