Clinical trial NCT00192972: A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation
Official title: A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmia
Keywords: Catheter ablation
Atrial fibrillation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Biosense Webster, Inc.
name: Abbott Medical Devices
name: Guidant Corporation
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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

Eligibility criteria: 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)

Primary outcomes:
measure: overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
Secondary outcomes:
measure: - safety
measure: - resumption of LA-PV conduction
measure: - neurohormones
measure: - socio-economics (cost effectiveness)
measure: - inflammatory markers
measure: - quality of life
measure: - signal averaged P wave signals-
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Righospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Brian Nilsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Righospitalet, Copenhagen, Denmark
name: Xu Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Righospitalet, Copenhagen, Denmark
name: Steen M Pehrson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Righospitalet, Copenhagen, Denmark
name: Lars Køber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of biostatistics, University of Copenhagen
name: Jørgen Hilden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Righospitalet, Copenhagen, Denmark
name: Jesper H Svendsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/01.CIR.0000146786.87037.26. Epub 2004 Oct 25.