Early ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy
Key facts
- Where
- Warsaw, LengyelországSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Lengyelország
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Trial code
- EU 2023-508743-43-00
- Record updated
- 2024. szeptember 16.
- Original description
The aim of the study is to compare 3 strategies (2 based on pharmacotherapy and invasive methods of early ablation) to prevent recurrence of atrial fibrillation (AF) in patients diagnosed with hypertrophic cardiomyopathy (HCM). more effective than two alternative pharmacotherapy strategies compared in the study: 1. use of amiodarone or 2. only beta-blocker or sotalol. Population: 725 patients diagnosed with HCM will be included in the observation phase of the study and subsequently 300 with documented AF > 30 sec. episode will be included in randomized therapeutic intervention phase.Read full original descriptionShow less
The aim of the study is to compare 3 strategies (2 based on pharmacotherapy and invasive methods of early ablation) to prevent recurrence of atrial fibrillation (AF) in patients diagnosed with hypertrophic cardiomyopathy (HCM). more effective than two alternative pharmacotherapy strategies compared in the study: 1. use of amiodarone or 2. only beta-blocker or sotalol. Population: 725 patients diagnosed with HCM will be included in the observation phase of the study and subsequently 300 with documented AF > 30 sec. episode will be included in randomized therapeutic intervention phase.
Inclusion: 1.diagnosed hypertrophic cardiomyopathy as defined by the European Society of Cardiology, 2. signed informed consent to participate in the study, 3. 18 years of age or more.
Exclusion: age <18 years of age, 2. permanent atrial fibrillation, 3. previous treatment with amiodarone, 4. absolute contraindications to ablation treatment or absolute contraindications to amiodarone administration, 5. left atrium size in short axis echocardiography > 5.5 cm or four-chamber view LA area> 35 cm2, 6. NYHA class IV heart failure, 7. double-determined left ventricular ejection fraction <30% despite optimal treatment; including at least 1 record on sinus rhythm, 8. pregnancy or breastfeeding, 9. participation in another clinical trial, 10. expected non-compliance during the study, 11. absolute contraindication to magnetic resonance imaging, 12. other important reason which, due to the researcher opinion, does not qualify the patient to participate in the study 13.Lack of consent to use contraception during the study and during the obligatory period to use contraception after the study for one month. 14.Decompensated thyroid dysfunction 15.• Indication for simultaneous use of drugs that prolong the QT interval ((class Ia antiarrhythmic drugs, e.g.: quinidine, procainamide, disopyramide; class III antiarrhythmic drugs, e.g. sotalol, bretylium; erythromycin, cotrimoxazole, pentamidine; some antipsychotics or antidepressants, e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride and sertindole; lithium preparations and tricyclic drugs, e.g. doxepin, maprotiline, amitriptyline, some antihistamines, e.g. terfenadine, astemizole, mizolastine).