2023-508743-43-00CompletedPhase 4
Early ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 725 (actual)
- First submitted
- 27 Oct 2023
- Start date
- 1 Jan 2024
- Lead sponsor
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Diseases
- Atrial fibrillation, Heart failure, High blood pressure, Hypertrophic cardiomyopathy, Stroke
- EU CT number
- 2023-508743-43-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 725
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy | Warsaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.