Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Phase 3

Completed

• Conditions: Atrial Fibrillation; Hypertrophic Cardiomyopathy
• Interventions: Procedure: RF catheter ablation; Drug: Antiarrhythmic drugs

• Registration Number: NCT00821353
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-11
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFCA	RF catheter ablation	-
Drug	Antiarrhythmic drugs	-

Primary Outcome Measures

Name	Time	Method
Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in level of Nt-pro-BNP.	1 year
Changes in symptom severity and quality of life.	1 year
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 exercise capacity assessed by cardiopulmonary exercise testing.	1 year

Trial Locations

Locations (1)

Institute of Cardiology; 🇵🇱 Warsaw, Poland