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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- 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).
- 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
- Quality of life-score
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
|Department of Cardiology, Skejby University Hospital|
|Aarhus, Denmark, 8200|
|Principal Investigator:||Peter Steen Hansen, MD, DMSc|
|Principal Investigator:||Jens Cosedis Nielsen, MD, PhD|
|Principal Investigator:||Steen Hvitfeldt Poulsen, MD, DMSc||Unaffilliated|