Heart Failure Clinical Trial
— SAFEOfficial title:
Surgical Ablation of AF Efficacy Trial
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 31, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years; - Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof; - Documented history of paroxysmal or persistent AF - Provide informed consent Exclusion Criteria: - Dominant atrial arrhythmia is atrial flutter; - Documented left atrial diameter = 6 cm; - Previous cardiac surgery requiring opening of the pericardium; - Patients undergoing any of the following procedures: 1. Heart transplant 2. Complex congenital heart surgery 3. Sole indication for surgery is ventricular assist device insertion 4. Mitral valve repair or replacement 5. Tricuspid valve repair or replacement - Patient resides in a long-term care facility |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Population Health Research Institute | Hamilton Health Sciences Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Ischemic stroke and systemic arterial embolism | Safety outcome | Up to 30 days post-operatively | |
Other | Number of patients requiring permanent pacemaker implantation | Safety outcome | Up to 1 year post-operatively | |
Other | Volume of chest tube output | Safety outcome - chest tube output measured in mL. | Up to 24 hours post-operatively | |
Other | Re-operation for bleeding | Safety outcome | From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years) | |
Other | All-cause mortality | Safety outcome | Prior to discharge or within 30 days post-operatively (whichever occurs first) | |
Other | Post-operative major bleeding | Safety outcome | <48 hours after surgery | |
Other | Number of patients with pulmonary vein stenosis | Safety outcome | At 1 year, and at common termination point for trial (median follow-up of 4 years) | |
Other | Number of patients with stiff left atrium syndrome | Safety outcome | At 1 year, and at common termination point for trial (median follow-up of 4 years) | |
Other | Number of patients with esophageal to atrial fistula | Safety outcome | At 1 year, and at common termination point for trial (median follow-up of 4 years) | |
Other | Health economic analysis of surgical atrial fibrillation | Economic analysis will be assessed via health care utilization by patients | At 1 year, and at common termination point (median follow-up of 4 years) | |
Other | Health economic analysis of surgical atrial fibrillation | Economic analysis will be assessed via a questionnaire of health care visits and costs incurred by patients. | At 1 year, and at common termination point (median follow-up of 4 years) | |
Primary | Number of hospital readmissions for heart failure over duration of follow-up | Total number of hospital readmissions for heart failure. | Common termination point for trial (median follow-up of 4 years) | |
Secondary | Number of Ischemic stroke or systemic arterial embolism events over duration of follow up | Number of Ischemic stroke or systemic arterial embolism events over duration of follow up | Common termination point for trial (median follow-up of 4 years) | |
Secondary | Length of ICU stay | Length of ICU stay, including readmissions, from study intervention surgery to hospital discharge, including readmissions | From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years) | |
Secondary | Length of hospital stay | Length of hospital stay | From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years) | |
Secondary | Freedom from recurrence of atrial tachyarrhythmia | Freedom from recurrence of atrial tachyarrhythmia | 1 year post-operatively | |
Secondary | Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure | Number of days free admission to healthcare facility or presentation to the emergency department for heart failure | Common termination point for trial (median follow-up of 4 years) | |
Secondary | All-cause mortality | All-cause mortality | Common termination point for trial (median follow-up of 4 years) | |
Secondary | Cardiovascular mortality | Cardiovascular mortality | Common termination point for trial (median follow-up of 4 years) | |
Secondary | Antiarrhythmic drug use | Antiarrhythmic drug use | Beyond 6 weeks until common termination point for trial (median follow-up of 4 years) | |
Secondary | Number of patients undergoing atrial fibrillation ablation | Number of patients undergoing atrial fibrillation ablation | 90 days post- study surgery until common termination point for trial (median follow-up of 4 years) | |
Secondary | Quality of Life - atrial fibrillation specific | Atrial fibrillation specific quality of life as assessed by the Atrial Fibrillation Effect on QualiTy of Life questionnaire (AFEQT) which is 20 questions using a 7 point Likert scale where a higher score means a worse outcome. | At 1 year, and at common termination point for trial (median follow-up of 4 years) | |
Secondary | Quality of Life - heart failure specific | Heart failure specific quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) which is a 12 questions using Likert scales where a higher score is a better outcome. | At 1 year, and at common termination point for trial (median follow-up of 4 years) | |
Secondary | Quality of Life - General | Quality of life- general as assessed by the European quality of life index version 5D (EQ-5D-5L) which consists of a descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | At 1 year, and at common termination point for trial (median follow-up of 4 years) |
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