Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203241

Enrollment

120

Registered

2010-09-16

Start date

2009-06-30

Completion date

2012-12-31

Last updated

2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-refractory Paroxysmal Atrial Fibrillation

Brief summary

The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.

Interventions

PROCEDUREPulmonary vein encircling

Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum

PROCEDUREPulmonary vein encircling plus roof ablation

Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Drug-refractory paroxysmal atrial fibrillation

Exclusion criteria

* Hypo or hyperthyroidism * Implantable defibrillation or pacemaker implanted * Moderate or severe mitral valve disease or mitral prosthetic valve * Ejection fraction less than 30% * Left atrial anteroposterior diameter more than 50 mm. * Previous atrial fibrillation ablation * Left atrium thrombus * Current infective disease or sepsis * Pregnant women * Current unstable angor * Acute myocardial infarction in last 3 months * Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease * Reduced expectancy of life (less than 12 months) * Patient participating in another clinical study that investigates a drug or device * Psychologically unstable patient or denies to give informed consent

Design outcomes

Primary

Measure	Time frame
Freedom from atrial arrhythmias without antiarrhythmic drugs	1-year follow-up

Secondary

Measure	Time frame
Freedom from atrial arrhythmias with or without antiarrhythmic drugs	1-year follow-up
Presence of any complications in the acute phase or during follow-up	1-year follow-up

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026