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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00821353
Date of registration: 11/01/2009
Prospective Registration: Yes
Primary sponsor: Institute of Cardiology, Warsaw, Poland
Public title: Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Scientific title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)
Date of first enrolment: January 2009
Target sample size: 90
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00821353
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Poland
Contacts
Name:     Franciszek Walczak, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Institute of Cardiology, Warsaw, Poland
Name:     Lidia Chojnowska, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Institute of Cardiology, Warsaw, Poland
Name:     Lukasz Szumowski, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Institute of Cardiology, Warsaw, Poland
Name:     Pawel Derejko, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Institute of Cardiology, Warsaw, Poland
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Atrial Fibrillation
Hypertrophic Cardiomyopathy
Intervention(s)
Drug: Antiarrhythmic drugs
Procedure: RF catheter ablation
Primary Outcome(s)
Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. [Time Frame: 1 year]
Secondary Outcome(s)
Changes in total symptomatic and asymptomatic AF burden. [Time Frame: 1 year]
Changes in exercise capacity assessed by cardiopulmonary exercise testing. [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]
Incidence of complications. [Time Frame: 1 year]
Secondary ID(s)
1.7/IV/08
N N402 194635
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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