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.

Myocardial and systemic response in patient undergoing mitral valve surgery with and without concomitant maze ablation for atrial fibrillation. Patients scheduled for maze treatment are randomized to ablation with cryo or radio frequency (RF) device.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14454361

Enrollment

150

Registered

2015-01-05

Start date

2013-09-01

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1. Non intervention: Mitral valve surgery with or without other cardiac procedures. 2. Intervention 1: Mitral valve surgery with or without other cardiac procedures and concomitant cry

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) 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)	—

Measure

Time frame

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) 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)

—

Secondary

Measure	Time frame
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) 2. Atrial size and contractile function: measured with echocardiography on the preoperative day and at 1 year follow up Rate of stable sinus rhythm at 1 year follow up: measured with 48 hrs electrocardiogram monitors.	—

Measure

Time frame

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) 2. Atrial size and contractile function: measured with echocardiography on the preoperative day and at 1 year follow up Rate of stable sinus rhythm at 1 year follow up: measured with 48 hrs electrocardiogram monitors.

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026