Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821353
• Other study ID #: N N402 194635
• Secondary ID: 1.7/IV/08
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2009
• Last updated: February 4, 2013
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• RF catheter ablation
RF catheter ablation

Drug:
• Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.		1 year	No
Secondary	Changes in total symptomatic and asymptomatic AF burden.		1 year	No
Secondary	Incidence of complications.		1 year	Yes
Secondary	Changes in left atrial diameter and left ventricular function.		1 year	No
Secondary	Changes in level of Nt-pro-BNP.		1 year	No
Secondary	Changes in symptom severity and quality of life.		1 year	No
Secondary	Changes in exercise capacity assessed by cardiopulmonary exercise testing.		1 year	No