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

Atrial Fibrillation Clinical Trial

Official title:

A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192972
• Other study ID #: LASCAR
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 21, 2005
• Start date: November 2002
• Est. completion date: June 2005

Study information

• Verified date: November 2003
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation (pulmonary vein isolation)

Locations

Country	Name	City	State
Denmark	Righospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Biosense Webster, Inc., Guidant Corporation, Medtronic, St. Jude Medical

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Oral H, Chugh A, Lemola K, Cheung P, Hall B, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Morady F. Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study. Circulation. 2004 Nov 2;110(18):2797-801. Epub 2004 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
Secondary	- safety
Secondary	- resumption of LA-PV conduction
Secondary	- neurohormones
Secondary	- socio-economics (cost effectiveness)
Secondary	- inflammatory markers
Secondary	- quality of life
Secondary	- signal averaged P wave signals-