NCT01896570

Brief Summary

In this study, the investigators aim to examine the prognostic role of subsequent Atrial Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the investigators compare patients who were randomly assigned to either undergo cardioversion after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

3.8 years

First QC Date

July 6, 2013

Last Update Submit

July 10, 2013

Conditions

Keywords

atrial fibrillationcatheter ablationsubsequent atrial tachycardiamechanisms

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia-free survival

    24 months after enrolment

Secondary Outcomes (1)

  • Type of Arrhythmia recurrence

    24 months after enrolement

Other Outcomes (1)

  • Time to recurrence

    after blanking period (3 months) until study end (at least 24 months)

Study Arms (2)

Group A: cardioversion at AT

after achievement of AT, pts were cardioverted

Group B: ablation to SR

After AT has been achieved, all subsequent AT were ablated with the endpoint of procedural SR termination

Procedure: Catheter ablation of subsequent atrial tachycardia

Interventions

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with persistent AF

You may qualify if:

  • persistent AF for at least 1 months,
  • age \> 18 years,
  • refractory to drug therapy,
  • no prior ablation

You may not qualify if:

  • prior AF ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Eppendorf, Dept. of Electrophysiology

Hamburg, D-20246, Germany

Location

Related Publications (1)

  • Rostock T, Salukhe TV, Hoffmann BA, Steven D, Berner I, Mullerleile K, Theis C, Bock K, Servatius H, Sultan A, Willems S. Prognostic role of subsequent atrial tachycardias occurring during ablation of persistent atrial fibrillation: a prospective randomized trial. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1059-65. doi: 10.1161/CIRCEP.113.001019. Epub 2013 Oct 25.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

July 6, 2013

First Posted

July 11, 2013

Study Start

June 1, 2009

Primary Completion

March 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations