Atrial Fibrillation
Conditions
Keywords
Catheter ablation, Low voltage
Brief summary
Brief summary: The objective of this study is to compare two different ablation strategies in participants with persistent atrial fibrillation and fibrotic areas in the left atrium. The participant will be randomized to pulmonary vein isolation or pulmonary vein isolation plus ablation of fibrotic areas.
Detailed description
Background: Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence of 2-3 percent in the population. Catheter ablation performing pulmonary vein isolation (PVI) is an established treatment, which aim to eliminate triggers from the pulmonary veins. This treatment is successful in most patients with paroxysmal AF. In many patients, especially the patients with persistent AF, this treatment is not sufficiently to achieve freedom from arrhythmia and symptoms. There are several studies showing that fibrosis in the left atrium (LA) is an independent factor to relapse in AF after PVI. The fibrotic areas can be detected by measuring the voltage in the left atrium and creating a voltage map. There are non-randomized studies that suggest better results regarding reduction of arrhythmia burden after ablating the low voltage areas (LVAs). This ablation strategy is commonly used in clinical praxis although there are no randomized studies in this field. Aim: The objective of this study is to compare two different ablation strategies in participants with persistent atrial fibrillation and fibrotic areas in the left atrium. The participant will be randomized to PVI versus PVI plus ablation of LVAs. The primary endpoint is freedom of atrial arrhythmias after 1 to 2 ablation procedures within 6 months measured at 12 months after the first ablation procedure without antiarrhythmic drugs. Secondary endpoints will be atrial arrhythmia burden, health related quality of life measured by AFEQT score, and RAND 36 and periprocedural complications; death, stroke/ TIA, tamponade, atrio-esophageal fistula, and atrioventricular block. Study design: Randomized controlled multicenter trial. The study will be single blinded. All the participants will undergo PVI and the substrate map will be collected during atrial pacing. The patients with LVA will be randomized in a 1:1 fashion to; PVI plus ablation of LVA or PVI alone. Follow up visits will be at 3, 6, 12, 18 and 24 months. Before ablation and at every follow up visit the participants will fill in arrhythmia symptom specific questionnaires (AFEQT and ASTA) and questionnaire about quality of life (RAND 36). The participants will register arrhythmia with a heart monitoring system if symptoms of arrhythmia and two times daily during two weeks before every follow up visit.
Interventions
PROCEDURERadio frequency ablation
Two different radio frequency ablation procedures
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomization 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition 2. Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation. 3. Suitable candidate for catheter ablation. 4. Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs 5. Age ≥18 years.
Exclusion criteria
1. LA dimension \>55 mm as determined by an echocardiography within the previous year 2. Acute coronary syndrome or coronary artery bypass surgery within 12 weeks 3. Severe aortic or mitral valvular heart disease using the ESC guidelines 4. Congenital heart disease 5. Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation 6. Medical condition likely to limit survival to \< 1 year 7. New York Heart Association (NYHA) class IV heart failure symptoms 8. Contraindication to oral anticoagulation 9. Renal failure requiring dialysis 10. AF due to reversible cause 11. Pregnant and fertile women without anticonception 12. History of non-compliance to medical therapy 13. Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Freedom from Atrial Arrhythmia | From 3 months (blanking period) to 12 months after the first ablation procedure | Freedom from documented atrial arrhythmias \>30 seconds at 12 months after 1 or 2 ablation procedures within 6 months without antiarrhythmic drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Freedom from Atrial Arrhythmia after 1 Ablation Procedure without Antiarrhythmic Drugs (AAD) | From 3 months (blanking period) to 12 months after the first ablation procedure | Freedom from documented atrial arrhythmias \>30 seconds at 12 months after 1 ablation procedure without antiarrhythmic drugs |
| Number of Participants with Freedom from Atrial Arrhythmia after 1 Ablation Procedure with/ without AAD | From 3 months (blanking period) to 12 months after the first ablation procedure | Freedom from documented atrial arrhythmias \>30 seconds at 12 months after 1 ablation procedure with or without antiarrhythmic drugs |
| Number of Participants with Freedom from Atrial Arrhythmia after 1 or 2 Ablation Procedures with/ without AAD | From 3 months (blanking period) to 12 months after the first ablation procedure | Freedom from documented atrial arrhythmias \>30 seconds at 12 months after 1 or 2 ablation procedures with or without antiarrhythmic drugs |
| Number of Participants with Freedom from Atrial Fibrillation | From 3 months (blanking period) to 12 months after the first ablation procedure | Freedom from documented atrial fibrillation \>30 seconds at 12 months after 1 or 2 ablation procedures without antiarrhythmic drugs |
| Number of Participants with Freedom from Symptomatic Atrial Arrhythmias | From 3 months (blanking period) to 12 months after the first ablation procedure | Freedom from documented symptomatic atrial arrhythmias \>30 seconds at 12 months after 1 or 2 ablation procedures with or without antiarrhythmic drugs |
| Number of Participants with Freedom from Atrial Arrhythmias without AAD | From 3 months (blanking period) to 24 months after the first ablation procedure | Freedom from documented atrial arrhythmias \>30 seconds at 24 months after 1 or several ablation procedures without antiarrhythmic drugs |
| Number of Participants with Freedom from Atrial Arrhythmias with or without AAD | From 3 months (blanking period) to 24 months after the first ablation procedure | Freedom from documented symptomatic atrial arrhythmias \>30 seconds at 24 months after 1 or several ablation procedures with or without antiarrhythmic drugs |
| Arrhythmia Burden | From 3 months (blanking period) to 12 months and 24 months after the first ablation procedure | Number of Registrations with Remote Heart Monitor / Number of Registrations with Atrial Arrhythmia with Remote Heart Monitor |
| Time to First Recurrens | From first ablation procedure to 24 months | Time from first ablation procedure to first documented recurrens of atrial arrhythmias |
| Number of Repeat Procedures | 12 and 24 months after the first ablation procedure | Number of repeat procedures |
| Changes in Quality of Life Measures: Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Overall Score and Subscale Scores | Baseline, 12 and 24 months after the first ablation procedure | AFEQT is a 21 questions atrial fibrillation specific health related quality of life questionnaire. Overall Score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. Score ranges from 0 to 100 points. Higher scores mean a better outcome. |
| Changes in Quality of Life Measures: RAND 36 (Research ANd Development) 36 All Domains | Baseline,12 and 24 months after the first ablation procedure | RAND 36 (developed by RAND corporation) is a 36 questions health related quality of life questionnaire. The RAND 36 is divided into 8 domains: Physical functioning, role physical, role emotional, bodily pain, vitality, general health, social functioning and mental health. Score range from 0 to 100 points. Higher scores mean a better outcome. |
| Number of Participants with Adverse Events/ Complications | 12 and 24 months after the first ablation procedure | Complications related to the ablation procedure: Cardiac perforation, stroke, transitory ischemic attack (TIA), systemic embolic events, atrio-esophageal fistula, major bleeding, atrioventricular block, groin hematoma requiring vascular surgery or extended hospitalization. |
| Number of Participants With All-cause Mortality | 12 and 24 months after the first ablation procedure | Number of Participants With All-cause Mortality |
| Procedure time | Immediately after the procedure | Time from start of groin punction to withdrawal of the catheters |
| Fluoroscopy time | Immediately after the procedure | Total fluoroscopy time during the procedure |
Countries
Sweden
Contacts
STUDY_DIRECTORMats Jensen-Urstad, MD
Karolinska University Hospital
Outcome results
None listed