Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery (CONTROL-AF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01360918|
Recruitment Status : Terminated (Inclusion rate insufficiënt)
First Posted : May 26, 2011
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Epicardial pulmonary vein isolation Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2014|
|Active Comparator: Usual care||
Other: Usual care
Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.
|Active Comparator: Pulmonary vein isolation||
Device: Epicardial pulmonary vein isolation
After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.
Other Name: Medtronic Cardioblate BP2
- Recurrence of atrial fibrillation [ Time Frame: one year ]The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (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.
- Duration of hospitalization [ Time Frame: One year ]Secondary objectives include the duration of hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360918
|Medisch Spectrum Twente|
|Enschede, Overijssel, Netherlands|
|Principal Investigator:||Marcoen Scholten, MD PhD||Medisch Spectrum Twente|