Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03857711
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2019-02-22
Brief Title:
Randomized Clinical Trial PULVAB Prophylactic Pulmonary Veins Ablation
Sponsor:
National Research Center of Surgery Russia
Organization:
National Research Center of Surgery Russia
Study Overview
Official Title:
Multicenter Randomized Clinical Trial PULVAB Prophylactic Pulmonary Veins Ablation
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULVAB
Brief Summary:
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF
Detailed Description:
Prospective multicenter randomized trial intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation
The study includes 4 groups of patients
Group I conventional CABG
Group II CABG pulmonary veins isolation Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation
Group III CABG pulmonary veins isolation amiodarone Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode
Group IV CABG amiodarone Conventional CABG with administration of amiodarone in postoperative periode
The study includes 4 groups of patients
Group I conventional CABG
Group II CABG pulmonary veins isolation Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation
Group III CABG pulmonary veins isolation amiodarone Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode
Group IV CABG amiodarone Conventional CABG with administration of amiodarone in postoperative periode
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None