A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrhythmia

• Registration Number: NCT00192972
• Lead Sponsor: Rigshospitalet, Denmark

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.

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

Study Timeline

• Study Start: 2002-11
• Status Verified: 2003-11
• Study Completion: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Last Update Submitted: 2005-12-21
• Last Update Posted: 2005-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- safety
- resumption of LA-PV conduction
- neurohormones
- socio-economics (cost effectiveness)
- inflammatory markers
- quality of life
- signal averaged P wave signals-

Trial Locations

Locations (1)

Righospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark