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Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00821353
First Posted: January 13, 2009
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Cardiology, Warsaw, Poland
January 11, 2009
January 13, 2009
February 5, 2013
January 2009
June 2012   (Final data collection date for primary outcome measure)
Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00821353 on ClinicalTrials.gov Archive Site
  • Changes in total symptomatic and asymptomatic AF burden. [ Time Frame: 1 year ]
  • Incidence of complications. [ Time Frame: 1 year ]
  • Changes in left atrial diameter and left ventricular function. [ Time Frame: 1 year ]
  • Changes in level of Nt-pro-BNP. [ Time Frame: 1 year ]
  • Changes in symptom severity and quality of life. [ Time Frame: 1 year ]
  • Changes in exercise capacity assessed by cardiopulmonary exercise testing. [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Hypertrophic Cardiomyopathy
  • Procedure: RF catheter ablation
    RF catheter ablation
  • Drug: Antiarrhythmic drugs
    One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
  • Active Comparator: RFCA
    Intervention: Procedure: RF catheter ablation
  • Active Comparator: Drug
    Intervention: Drug: Antiarrhythmic drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00821353
N N402 194635
1.7/IV/08
No
Not Provided
Not Provided
Pawel Derejko M.D. Ph.D., Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
Not Provided
Principal Investigator: Pawel Derejko, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Lidia Chojnowska, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Lukasz Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Franciszek Walczak, MD, PhD Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP