Atrial Fibrillation Clinical Trial
Official title:
Pulsed-field Catheter Ablation as the First-line Treatment for Asymptomatic Non-paroxysmal Atrial Fibrillation
The goal of the study is to test the hypothesis whether the treatment of patients with asymptomatic non-paroxysmal AF based on catheter ablation will be superior than conservative approach consisting of electrical cardioversion with AADs treatment in terms of significant improvement of functional exercise capacity. Secondary hypothesis is that mild functional improvement would be present also by achieving optimum heart rate by means of the titration of beta-blocker dose. Patients with non-paroxysmal asymptomatic AF will be enrolled and randomized to either early invasive strategy arm (EIS;, i.e. catheter ablation), or conservative arm (CS; ie. cardioversion followed by antiarrhythmic drug treatment. As baseline examinations, functional cardiopulmonary exercise testing (CPET), Holter, recording, and echocardiography will be done. After one month, the procedure (catheter ablation or cardioversion) will be performed. Outpatients visits are scheduled at 3, 6, 9 and 12 months after the randomization. At each visit, ECG Holter recording will be done. CPET will be repeated at M3 and M12 visits. In patients in the CS arm with AF recurrence, the dose of BB will be optimized using smart watches (the goal < 110/min on average, but to achieve 75% of predicted maximum heart rate). The endpoint will be the change in VO2 max between baseline and 12M CPET. Secondary endpoints will be AF burden, AF freedom, the change in the concentration of NT-proBNP, the change in the left atrial diameter and left ventricular ejection fraction, the proportion of patients with no improvement while in SR, and the improvement in the quality-of-life at 12 months.
Status | Not yet recruiting |
Enrollment | 124 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - non-paroxysmal AF - absence of symptoms during standard clinical evaluation - AFEQT> 80 - NT-pro BNP < 800 pg/mL Exclusion Criteria: - significant valvular disease - left ventricular dysfunction - LV EF < 50 % - history of tachycardia - induced cardiomyopathy - pulmonary hypertension (sPAP > 40 mm Hg) - age > 75 years - LA size > 60 mm - physical limitations that don't enable functional cardiopulmonary exercise testing - overt coronary artery disease - pregnancy - BMI > 40 - chronic obstructive pulmonary disease with moderate or severe obstruction - life expectancy less than 2 years - permanent AF - ophthalmological medication (eye drops) containing beta-blockers |
Country | Name | City | State |
---|---|---|---|
Czechia | Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady | Prague |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic | Brno University Hospital, Nemocnice AGEL Trinec-Podlesi a.s., Regional Hospital Liberec, University Hospital Ostrava, VFN |
Czechia,
Fiala M, Bulkova V, Sknouril L, Nevralova R, Toman O, Januska J, Spinar J, Wichterle D. Functional improvement after successful catheter ablation for long-standing persistent atrial fibrillation. Europace. 2017 Nov 1;19(11):1781-1789. doi: 10.1093/europac — View Citation
Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbüchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S,
Wokhlu A, Monahan KH, Hodge DO, Asirvatham SJ, Friedman PA, Munger TM, Bradley DJ, Bluhm CM, Haroldson JM, Packer DL. Long-term quality of life after ablation of atrial fibrillation the impact of recurrence, symptom relief, and placebo effect. J Am Coll C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in VO2 max | The change in VO2 max during baseline and 12 month functional CardioPulmonary Exercise Testing | 12 months | |
Secondary | Sinus rhythm maintenance | The time to the first reoccurrence of atrial fibrillation | 12 monthhs | |
Secondary | AF burden | The percentage of time spent in atrial fibrillation during all Holter recordings | 12 months | |
Secondary | Proportion of really asymptomatic patients | The proportion of patients with no significant improvement during cardiopulmonary exercise testing while in SR, and no subjectively reported improvement | 12 months | |
Secondary | VO2 max change in patients with atrial fibrillation reoccurrence | Change in VO2 max between the cardiopulmonary exercise testing at baseline and at 12 months in patients, who had atrial fibrillation reoccurrence and in whom bradycardia medication was optimized | 12 months | |
Secondary | NT-pro BNP | Change in the concentrations of NT-pro BNP between baseline and 12 month examinations, comparison between groups | 12 months | |
Secondary | Left atrial dimension and left ventricular ejection fraction | Changes in the left atrial dimension and left ventricular ejection fraction between baseline and 12 examinations, comparison between groups | 12 months |
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