Concomitant epicardial pulmonary vein isolation in patients with atrial fibrillation undergoing elective cardiac surgery

Concomitant epicardial pulmonary vein isolation in patients with atrial fibrillation undergoing elective cardiac surgery - CONTROL-AF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36466

Enrollment

Registered

2011-03-29

Start date

2011-08-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

atrial fibrillation

Interventions

Concomitant epicardial pulmonary vein isolation versus *usual care* based on a 1:1 randomization strategy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients >= 18 years of age EHRA class

Exclusion criteria

Exclusion criteria: Patients >=70 years of age Pregnancy Patients with contraindications for oral anticoagulant agents. Patients undergoing emergency operation Patients undergoing concomitant valve replacement Severely enlarged LA (>50 mm) on echocardiography Prior AF ablation or AF surgery

Design outcomes

Primary

Measure	Time frame
The percentage of patients without a recurrence of AF, without AADs, within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration. The percentage of patients without post-operative atrial fibrillation during admission. An episode of AF is defined as an episode of at least 30 seconds duration.	—

Measure

Time frame

The percentage of patients without a recurrence of AF, without AADs, within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration. The percentage of patients without post-operative atrial fibrillation during admission. An episode of AF is defined as an episode of at least 30 seconds duration.

—

Secondary

Measure	Time frame
Secondary outcomes include comparison of cost and duration of hospitalization, post-procedural discomfort and experienced AF burden during follow-up.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)