A FACT (Atrial Fibrillation ablation and AutonomiC modulation via Thoracoscopic Surgery). A randomized single center study to prospectively investigate the effect of ablation of the autonomic ganglia in addition to minimally invasive surgical isolation of the pulmonary veins in patients with atrial fibrillation.

A FACT (Atrial Fibrillation ablation and AutonomiC modulation via Thoracoscopic Surgery). A randomized single center study to prospectively investigate the effect of ablation of the autonomic ganglia in addition to minimally invasive surgical isolation of the pulmonary veins in patients with atrial fibrillation. - A FACT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34819

Enrollment

275

Registered

2010-09-23

Start date

2010-03-23

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Atrial Fibrillation Fibrillation

Interventions

In patients randomized to additional GP ablation, the following procedures will be carried out during the totally thoracoscopic procedure in addition to the PV isolation (and extended lesion set whe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with paroxysmal or persistent atrial fibrillation, refractory to at least one antiarrhythmic drug, between 18 and 80 years of age and willing to participate in the study and the follow-up

Exclusion criteria

Exclusion criteria: Catheter treatment for atrial fibrillation within 4 months before inclusion, myocardial infarction within the previous 2 months, heart failure, stroke in the previous 6 months, refuse to take medication, severely enlarged left atrium.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is freedom of AF after one and two years after the procedure with or without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of AF on serial Holter recordings during follow up and on ECGs recorded outside the scope of the study. One single episode of	—

Secondary

Measure	Time frame
The secondary endpoints include: 1) Freedom of AF after one and two years after the procedure without the use of any antiarrhythmic drug. Definition of freedom of AF as above. 2) Improvement of functional status as measured by the RAND 36 quality of life questionnaires	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)