Trials / Completed
CompletedNCT00192972
A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation
A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (planned)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure. Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction. Secondary endpoints were: * safety * resumption of LA-PV conduction * alterations in neurohormones * socio-economics aspects(cost effectiveness) * changes in inflammatory markers * quality of life * alterations in signal averaged P wawe signals * evaluation of the predictive value of these variables to predict recurrence of AF
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Catheter ablation (pulmonary vein isolation) |
Timeline
- Start date
- 2002-11-01
- Completion
- 2005-06-01
- First posted
- 2005-09-19
- Last updated
- 2005-12-22
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00192972. Inclusion in this directory is not an endorsement.