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Cavotricuspid Isthmusblock and Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00247780
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : February 18, 2008
Sponsor:
Collaborators:
Danish Heart Foundation
H. Lundbeck A/S
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Pulmonary vein isolation and cavotricuspid ishtmusblock Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cavotricuspid Isthmusblock and Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Study Start Date : November 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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Primary Outcome Measures :
  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 Outcome Measures :
  1. Asymptomatic AF or atrial flutter documented by ECG or Holter
  2. Macro-reentrant left atrial flutter
  3. Left atrial dimension
  4. Segmental tissue velocities ad amplitude in the left and right atria
  5. Plasma ANP/NT-pro-BNP
  6. Quality of life-score


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247780


Locations
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Denmark
Department of Cardiology, Skejby University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Danish Heart Foundation
H. Lundbeck A/S
Investigators
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Principal Investigator: Peter Steen Hansen, MD, DMSc
Principal Investigator: Jens Cosedis Nielsen, MD, PhD
Principal Investigator: Steen Hvitfeldt Poulsen, MD, DMSc Unaffilliated

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Responsible Party: Jacob Pontoppidan, University of Aarhus
ClinicalTrials.gov Identifier: NCT00247780     History of Changes
Other Study ID Numbers: JAP-PV-01
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008

Keywords provided by University of Aarhus:
Atrial fibrillation
Pulmonary vein isolation
Tissue Doppler echocardiography

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes