Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

National Institute of Cardiology, Warsaw, Poland

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Hypertrophic Cardiomyopathy

Treatments: Drug: Antiarrhythmic drugs; Procedure: RF catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00821353

N N402 194635

1.7/IV/08

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

RFCA

Active Comparator group

Treatment:

Procedure: RF catheter ablation

Drug

Active Comparator group

Treatment:

Drug: Antiarrhythmic drugs