NCT00192972

Brief Summary

Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

December 22, 2005

Status Verified

November 1, 2003

First QC Date

September 12, 2005

Last Update Submit

December 21, 2005

Conditions

Atrial FibrillationArrhythmia

Keywords

Catheter ablationAtrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)

Secondary Outcomes (7)

  • - safety

  • - resumption of LA-PV conduction

  • - neurohormones

  • - socio-economics (cost effectiveness)

  • - inflammatory markers

  • +2 more secondary outcomes

Interventions

Catheter ablation (pulmonary vein isolation)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens

You may not qualify if:

  • congenital heart disease
  • age under 18 years
  • significant valve disease
  • left atrial size \> 55 mm
  • prior ablation for AF
  • Severe heart failure (LVEF \< 20 % and/or NYHA class IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Righospitalet, Copenhagen University Hospital

Copenhagen, DK-2199, Denmark

Location

Related Publications (1)

  • Oral H, Chugh A, Lemola K, Cheung P, Hall B, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Morady F. Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study. Circulation. 2004 Nov 2;110(18):2797-801. doi: 10.1161/01.CIR.0000146786.87037.26. Epub 2004 Oct 25.

    PMID: 15505091BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Brian Nilsson, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Xu Chen, MD

    Righospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Steen M Pehrson, MD

    Righospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Lars Køber, MD

    Righospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Jørgen Hilden, MD

    Department of biostatistics, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Jesper H Svendsen, MD

    Righospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

November 1, 2002

Study Completion

June 1, 2005

Last Updated

December 22, 2005

Record last verified: 2003-11

Locations

DK(1)