A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device-based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre-existing atrial fibrillation

Papworth Hospital NHS Foundation Trust (UK)0 sites352 target enrollmentApril 4, 2008

Overview

Phase: 未知
Intervention: Not specified
Conditions: Patients with pre-existing atrial fibrillation (AF) requiring elective cardiac surgery
Sponsor: Papworth Hospital NHS Foundation Trust (UK)
Enrollment: 352
Status: Completed
Last Updated: 4 years ago

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29701167 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35348642/ five-year results (added 30/03/2022)

Registry

who.int

Start Date

April 4, 2008

End Date

February 29, 2012

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Papworth Hospital NHS Foundation Trust (UK)

•1\. Age over 18, both males and females
•2\. Patients will have elective cardiac surgery planned (coronary surgery, valve surgery, combined coronary and valve surgery, any other cardiac surgery requiring cardiopulmonary bypass)
•3\. Patients will have a history of documented atrial fibrillation (chronic, persistent or paroxysmal) beginning more than 3 months before entry into the study
•4\. All patients will provide written informed consent to participation

•1\. Patients with previous cardiac operations
•2\. Patients having emergency or salvage cardiac operations
•3\. Patients whose surgery will not involve cardiopulmonary bypass
•4\. Patients who are unlikely to be available for follow\-up over a two\-year period
•5\. Patients who are deemed not competent to provide consent