Early ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy - FLC.IV/X/22

arodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy0 sites725 target enrollmentOctober 27, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: arodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Enrollment: 725
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 27, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

arodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•1\. 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 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)