Plain English Summary
Background and study aims
Atrial fibrillation (AF) is a heart condition which results in an irregular and often abnormally fast heart rate. Symptoms can include feeling dizzy, being short of breath and palpitations. Having the condition increases the risk of a stroke or, in extreme cases, heart failure. This is because AF can lead to blood clots forming in the heart, which may then be pumped into the general blood circulation and eventually block arteries in the brain. Treatment can include medicines called anti-arrhythmics which help restore a regular heart beat and antithrombotic treatment to stop blood clots from forming. Surgical ablation is a procedure where the diseased area of the heart is destroyed, causing electrically isolating scar lines. The abnormal electrical circuits caused by the diseased area then stops and a normal heartbeat restored. About 5-10% of patients scheduled for cardiac (heart) surgery have AF and surgical ablation is often done at the same time. There are a number of different methods/devices that can be used to destroy the diseased tissue, including freezing (cryo) or heating (using radio frequencies or microwaves) the area. Both these methods have proved to be effective treatments for AF. We want to compare the amount of myocardial (heart muscle) injury, degree of systemic inflammatory response and levels of biochemical markers for cell death in patients when they (a) undergo AF ablation with a cryo-device along with their cardiac surgery (b) undergo AF ablation with a radio frequency (RF) device along with their cardiac surgery and (c) undergo only their cardiac surgery. The atrial function and the heart rhythm will be compared between the groups one year after surgery.
Who can participate?
Adults who are at least 18, about to have elective mitral valve surgery and a history of atrial fibrillation.
What does the study involve?
For each participant, the decision on whether they should have treatment for their AF is made at a meeting involving cardiologists and cardiac surgeons and it is based on general recommendations. Those participants that are recommended for AF ablation are then randomly assigned to receive either the cryo or RF ablation procedure. The study involves taking blood samples at various points throughout the study, taking myocardial biopsies during the surgery, echocardiography examinations and monitoring the heartbeat.
What are the possible benefits and risks of participating?
There are no benefits for the participants in this study. There might be a slightly increased risk for postoperative bleeding from the myocardial biopsies and the blood samples taken for the study result in some additional blood loss.
Where is the study run from?
Dept. of Cardiothoracic and Vascular Surgery, University Hospital Linköping (Sweden)
When is the study starting and how long is it expected to run for?
September 2013 to December 2018
Who is funding the study?
ALF funding (Sweden)
Who is the main contact?
Dr Farkas Vánky
farkas.vanky@lio.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Farkas Vánky
ORCID ID
http://orcid.org/0000-0003-1005-091X
Contact details
Dept of Cardiothoracic and Vascular Surgery
University Hospital Linköping
Linköping
581 85
Sweden
-
farkas.vanky@lio.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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.
Acronym
RAFT-MSR
Study hypothesis
1. Atrial fibrillation (AF) treatment with maze procedure concomitant to mitral valve surgery results in higher levels of markers for myocardial injury, higher systemic inflammatory response, and elevated levels of markers for apoptosis.
2. Patients treated with concomitant cryo ablation and RF ablation have different levels of markers for myocardial injury, systemic inflammatory response, and levels of markers for apoptosis.
3. Concomitant AF treatment results in better atrial contractile function at one year follow up.
Added 20/10/2016:
4. Concomitant AF treatment with RF ablation results in better atrial contractile function than concomitant cryo ablation.
Ethics approval
Regional Ethical Review Board in Linköping, Sweden, 12/12/2012, ref. 2012/371-31
Added 20/10/2018:
refs: 2013/173-32, 2014/451-32, 2015/400-32
Study design
Single-centre, prospective randomized interventional study, also including a non-randomized arm for comparison.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in English. Existing information is written in Swedish.
Condition
Patients with pre-existing atrial fibrillation scheduled for elective mitral valve surgery.
Intervention
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 cryo-maze ablation device. Ablation lines according to Cox-Maze IV procedure.
3. Intervention 2: Mitral valve surgery with or without other cardiac procedures and concomitant radio frequency (RF)-maze ablation device. Ablation lines according to Cox-Maze IV procedure.
Intervention type
Device
Phase
Drug names
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/11/2012
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/09/2013
Recruitment end date
01/01/2018
Locations
Countries of recruitment
Sweden
Trial participating centre
University Hospital Linköping
Dept of Cardiothoracic and Vascular Surgery
Linköping
581 85
Sweden
Sponsor information
Organisation
University of Linköping, Dept. of Clinical Health and Science
Sponsor details
c/o Dr Farkas Vánky
Dept of Cardiothoracic and Vascular Surgery
University Hospital in Linköping
Linköping
581 85
Sweden
+46 10 103 00 00
farkas.vanky@lio.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
County Council of Östergötland - ALF funding (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary