ISRCTN82731440Completed未知
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 enrollmentStarted: April 4, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 352
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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