A randomised controlled trial to investigate the biochemical and myocardial effects of ablation for atrial fibrillation at concomitant elective cardiac surgery with two different methods, freezing versus heating.

Not Applicable

Completed

• Conditions: Surgery; Patients with pre-existing atrial fibrillation scheduled for elective mitral valve surgery.; Atrial fibrillation and flutter

• Registration Number: ISRCTN14454361
• Lead Sponsor: niversity of Linköping, Dept. of Clinical Health and Science

Brief Summary

2020 results in https://doi.org/10.1186/s41231-020-00064-z (added 07/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-05
• Study Completion: 2018-12-31
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Males and females, age over 18
2. Patients will have been accepted for elective mitral valve surgery (with or without additional cardiac procedures)
3. Patients will have a history of atrial fibrillation (chronic, persistent or paroxysmal), documented before decision on mitral valve surgery was made
4. All patients will provide written informed consent to participation

Exclusion Criteria

1. Patients having mitral surgery planned through minimal invasive access
2. Patients with active endocarditis
3. Patients having emergency or salvage cardiac operations
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Markers for myocardial injury: troponin T, creatinine kinase-MB, matrix metalloproteinase-2, tissue inhibitor of matrix metalloproteinase-2, myeloperoxidase (preoperatively, at skin closure, and 3 and 20 hrs postoperatively)<br> 2. Markers for inflammatory response: high sensitive C reactive protein, interleukins, tumour necrosis factors, tumour growth factors (preoperatively, at skin closure, and 3 and 20 hrs postoperatively)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Markers for heart failure and renal function: N-terminal pro brain natriuretic peptide (Nt-proBNP), Creatinine, Cystatin-C (preoperatively, 20 hrs postoperatively, 3 days postoperatively, and Nt-proBNP also at 1 year follow up)<br> 2. Atrial size and contractile function: measured with echocardiography on the preoperative day and at 1 year follow up<br><br> Rate of stable sinus rhythm at 1 year follow up: measured with 48 hrs electrocardiogram monitors.<br>