Atrial Fibrillation, Hypertrophic Cardiomyopathy
Conditions
Keywords
Atrial fibrillation, Hypertrophic cardiomyopathy, RF ablation, Antiarrhythmic drugs
Brief summary
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.
Interventions
PROCEDURERF catheter ablation
RF catheter ablation
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Changes in total symptomatic and asymptomatic AF burden. | 1 year |
| Incidence of complications. | 1 year |
| Changes in exercise capacity assessed by cardiopulmonary exercise testing. | 1 year |
| Changes in level of Nt-pro-BNP. | 1 year |
| Changes in symptom severity and quality of life. | 1 year |
| Changes in left atrial diameter and left ventricular function. | 1 year |
Countries
Poland
Outcome results
None listed