Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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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.

Official Title
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Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

Conditions
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Atrial Fibrillation, Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Procedure: RF catheter ablation
* Drug: Antiarrhythmic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation Exclusion Criteria: Severe hear failure (NYHA IV) Left ventricular ejection fraction <0.30 Left atrial diameter >65 mm Age > 70 years Contraindication to anticoagulation with warfarin Presence of a mechanical prosthetic valve Presence of left atrial thrombus on TEE or CT Woman currently pregnant Renal failure (GFR < 30 ml/min) Hepatic failure Untreated hypothyroidism or hyperthyroidism LVOT gradient > 50 mmHg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFCA<br> | Procedure: RF catheter ablation<br>* RF catheter ablation<br>|
| Active Comparator: Drug<br> | Drug: Antiarrhythmic drugs<br>* One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Hypertrophic cardiomyopathy, RF ablation, Antiarrhythmic drugs