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| ID | Type | Description | Link |
|---|---|---|---|
| 1.7/IV/08 |
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Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.
Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.
Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFCA | Active Comparator |
| |
| Drug | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF catheter ablation | Procedure | RF catheter ablation |
| |
| Antiarrhythmic drugs |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total symptomatic and asymptomatic AF burden. | 1 year | |
| Incidence of complications. | 1 year | |
| Changes in left atrial diameter and left ventricular function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pawel Derejko, MD, PhD | National Institute of Cardiology, Warsaw, Poland | Principal Investigator |
| Lidia Chojnowska, MD, PhD | National Institute of Cardiology, Warsaw, Poland | Principal Investigator |
| Lukasz Szumowski, MD, PhD | National Institute of Cardiology, Warsaw, Poland | Principal Investigator |
| Franciszek Walczak, MD, PhD | National Institute of Cardiology, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology | Warsaw | Poland |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Drug |
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF |
|
| 1 year |
| Changes in level of Nt-pro-BNP. | 1 year |
| Changes in symptom severity and quality of life. | 1 year |
| Changes in exercise capacity assessed by cardiopulmonary exercise testing. | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |