NCT00247780

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Pulmonary vein isolation (PVI) in the left atrium using radiofrequency energy is a new and promising non-medical treatment in patients with symptomatic AF with reported success rates of 65 % to 90 % depending on AF classification and ablation procedure. However, the risk of recurrence has led to suggestions of how to improve the clinical outcome by tailoring a more efficient ablation procedure. A prospective, randomised study with 150 patients with symptomatic AF referred for PVI has been initiated and patients are allocated to PVI alone (75 patients) or PVI with additional ablation in the right atrium (75 patients). Patients undergo extensive monitoring of the heart rhythm during follow-up to document symptomatic or asymptomatic AF or atrial flutter. The presence of asymptomatic AF after PVI could potentially affect the management of the anticoagulation therapy in these patients. The structural and functional changes in the atria after PVI is characterized by new imaging techniques (Tissue Doppler Imaging(TDI))of the atria and cardiac neurohormones. TDI may be an effective tool for characterising changes in the left atrial function after PVI. Neurohormones may provide new information regarding the changes in left atrial function and clinical outcome after PVI in patients with AF. We hypothesize that:

  • Among patients with predominant atrial fibrillation, PVI with additional ablation in the right atrium is associated with better outcome, i.e. freedom of symptomatic AF/atrial flutter overall.
  • Asymptomatic AF and atrial flutter occur frequently after PVI.
  • Left atrial volume and systolic function correlates to AF recurrence after PVI.
  • Neurohormones levels correlates to AF recurrence after PVI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Nov 2004

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, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 18, 2008

Status Verified

February 1, 2008

Enrollment Period

2.9 years

First QC Date

November 1, 2005

Last Update Submit

February 13, 2008

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationPulmonary vein isolationTissue Doppler echocardiography

Outcome Measures

Primary Outcomes (1)

  • Symptomatic AF or atrial flutter documented by ECG or Holter monitoring from the 3rd month* after the ablation (Definition: AF > 1 minute, atrial flutter > 1 minute of typical isthmusdependent flutter).

Secondary Outcomes (6)

  • Asymptomatic AF or atrial flutter documented by ECG or Holter

  • Macro-reentrant left atrial flutter

  • Left atrial dimension

  • Segmental tissue velocities ad amplitude in the left and right atria

  • Plasma ANP/NT-pro-BNP

  • +1 more secondary outcomes

Interventions

Pulmonary vein isolation and cavotricuspid ishtmusblockPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented symptomatic paroxysmal or persistent atrial fibrillation where medical treatment has proven inefficient or related to sideeffects.

You may not qualify if:

  • Prior cavotricuspid isthmus ablation (for atrial flutter) Significant valvular heart disease Congestive heart failure (NYHA class 3-4) Contraindications to antithrombic treatment with Warfarin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Skejby University Hospital

Aarhus, Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Steen Hansen, MD, DMSc

    PRINCIPAL INVESTIGATOR

  • Jens Cosedis Nielsen, MD, PhD

    PRINCIPAL INVESTIGATOR

  • Steen Hvitfeldt Poulsen, MD, DMSc

    Unaffilliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

November 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 18, 2008

Record last verified: 2008-02

Locations

DK(1)