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Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

NCT00821353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-02-05

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

RF catheter ablation

RF catheter ablation

DRUG

Antiarrhythmic drugs

One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Sponsors & Collaborators

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Pawel Derejko, MD, PhD · National Institute of Cardiology, Warsaw, Poland

  • Lidia Chojnowska, MD, PhD · National Institute of Cardiology, Warsaw, Poland

  • Lukasz Szumowski, MD, PhD · National Institute of Cardiology, Warsaw, Poland

  • Franciszek Walczak, MD, PhD · National Institute of Cardiology, Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821353 on ClinicalTrials.gov