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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
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation Hypertrophic Cardiomyopathy Procedure: RF catheter ablation Drug: Antiarrhythmic drugs Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RFCA Procedure: RF catheter ablation
RF catheter ablation
Active Comparator: Drug Drug: Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821353


Locations
Poland
Institute of Cardiology
Warsaw, Poland
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
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
  More Information

Responsible Party: Pawel Derejko M.D. Ph.D., Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT00821353     History of Changes
Other Study ID Numbers: N N402 194635
1.7/IV/08
First Submitted: January 11, 2009
First Posted: January 13, 2009
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Atrial fibrillation
Hypertrophic cardiomyopathy
RF ablation
Antiarrhythmic drugs

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Atrial Fibrillation
Cardiomyopathies
Hypertrophy
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Anti-Arrhythmia Agents


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