Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

This study has been completed.

Sponsor:

Information provided by:

Institute of Cardiology, Warsaw, Poland

ClinicalTrials.gov Identifier:

NCT00821353

First received: January 11, 2009

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2009

Last Updated Date

February 4, 2013

Start Date ^ICMJE

January 2009

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00821353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in total symptomatic and asymptomatic AF burden. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incidence of complications. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Changes in left atrial diameter and left ventricular function. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in level of Nt-pro-BNP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in symptom severity and quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in exercise capacity assessed by cardiopulmonary exercise testing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Official Title ^ICMJE

Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Atrial Fibrillation
Hypertrophic Cardiomyopathy

Intervention ^ICMJE

Procedure: RF catheter ablation
RF catheter ablation
Drug: Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Study Arm (s)

Active Comparator: RFCA
Intervention: Procedure: RF catheter ablation
Active Comparator: Drug
Intervention: Drug: Antiarrhythmic drugs

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00821353

Other Study ID Numbers ^ICMJE

N N402 194635, 1.7/IV/08

Has Data Monitoring Committee

Responsible Party

Pawel Derejko M.D. Ph.D., Institute of Cardiology, Warsaw, Poland

Study Sponsor ^ICMJE

Institute of Cardiology, Warsaw, Poland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Institute of Cardiology, Warsaw, Poland

Verification Date

February 2013

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

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