Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Information source: Institute of Cardiology, Warsaw, Poland
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation; Hypertrophic Cardiomyopathy
Intervention: RF catheter ablation (Procedure); Antiarrhythmic drugs (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Institute of Cardiology, Warsaw, Poland Official(s) and/or principal investigator(s):
Pawel Derejko, MD, PhD, Principal Investigator, Affiliation: Institute of Cardiology, Warsaw, Poland
Lidia Chojnowska, MD, PhD, Principal Investigator, Affiliation: Institute of Cardiology, Warsaw, Poland
Lukasz Szumowski, MD, PhD, Principal Investigator, Affiliation: Institute of Cardiology, Warsaw, Poland
Franciszek Walczak, MD, PhD, Principal Investigator, Affiliation: Institute of Cardiology, Warsaw, Poland
Overall contact:
Pawel Derejko, MD, PhD, Phone: +48 22 3434 326, Email: pderejko@yahoo.com
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.
Clinical Details
Official title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.
Secondary outcome: Changes in total symptomatic and asymptomatic AF burden.Incidence of complications. Changes in left atrial diameter and left ventricular function. Changes in level of Nt-pro-BNP. Changes in symptom severity and quality of life. Changes in exercise capacity assessed by cardiopulmonary exercise testing.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pawel Derejko, MD, PhD, Phone: +48 22 3434 326, Email: pderejko@yahoo.com
Institute of Cardiology, Warsaw, Poland; Recruiting
Pawel Derejko, MD, PhD, Phone: + 48 603 33 88 71, Email: pderejko@yahoo.com
Pawel Derejko, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2009
Ending date: September 2011
Last updated: September 30, 2009
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