Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
NCT ID: NCT00821353
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2009-01-31
2012-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RFCA
RF catheter ablation
RF catheter ablation
Drug
Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
Interventions
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RF catheter ablation
RF catheter ablation
Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Cardiology, Warsaw, Poland
OTHER
Responsible Party
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Institute of Cardiology, Warsaw, Poland
Principal Investigators
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Pawel Derejko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiology, Warsaw, Poland
Lidia Chojnowska, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiology, Warsaw, Poland
Lukasz Szumowski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiology, Warsaw, Poland
Franciszek Walczak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiology, Warsaw, Poland
Locations
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Institute of Cardiology
Warsaw, , Poland
Countries
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Other Identifiers
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1.7/IV/08
Identifier Type: -
Identifier Source: secondary_id
N N402 194635
Identifier Type: -
Identifier Source: org_study_id
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