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Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Primary Purpose

Atrial Fibrillation, Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
RF catheter ablation
Antiarrhythmic drugs
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Hypertrophic cardiomyopathy, RF ablation, Antiarrhythmic drugs

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RFCA

Drug

Arm Description

Outcomes

Primary Outcome Measures

Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.

Secondary Outcome Measures

Changes in total symptomatic and asymptomatic AF burden.
Incidence of complications.
Changes in left atrial diameter and left ventricular function.
Changes in level of Nt-pro-BNP.
Changes in symptom severity and quality of life.
Changes in exercise capacity assessed by cardiopulmonary exercise testing.

Full Information

First Posted
January 11, 2009
Last Updated
February 4, 2013
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT00821353
Brief Title
Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Official Title
Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Hypertrophic Cardiomyopathy
Keywords
Atrial fibrillation, Hypertrophic cardiomyopathy, RF ablation, Antiarrhythmic drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFCA
Arm Type
Active Comparator
Arm Title
Drug
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
RF catheter ablation
Intervention Description
RF catheter ablation
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drugs
Intervention Description
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
Primary Outcome Measure Information:
Title
Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in total symptomatic and asymptomatic AF burden.
Time Frame
1 year
Title
Incidence of complications.
Time Frame
1 year
Title
Changes in left atrial diameter and left ventricular function.
Time Frame
1 year
Title
Changes in level of Nt-pro-BNP.
Time Frame
1 year
Title
Changes in symptom severity and quality of life.
Time Frame
1 year
Title
Changes in exercise capacity assessed by cardiopulmonary exercise testing.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawel Derejko, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lidia Chojnowska, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lukasz Szumowski, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franciszek Walczak, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
Country
Poland

12. IPD Sharing Statement

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Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

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