Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF

NCT00643188 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2017-05-18

No results posted yet for this study

Summary

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher mortality, more frequent hospitalization, and lower quality of life. Furthermore, AF is often associated with heart failure. The majority of AF is initiated by ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation could improve cardiac function, symptoms and quality of life. It remains still unknown whether AF ablation is more effective than conventional treatment in terms of mortality and morbidity.

Conditions

Interventions

PROCEDURE

Radiofrequency ablation

Radiofrequency ablation of atrial fibrillation

OTHER

Conventional treatment

The best medical treatment according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult and the ACC/AHA/ESC 2006 Guidelines for Management of Patients with Atrial Fibrillation.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Johannes Brachmann, Prof. Dr. · Klinikum Coburg, Germany

  • Nassir F. Marrouche, Dr. · Division of Cardiology, University of Utah Health Sciences Cente, Salt Lake City, Utah, United States

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Australia
  • Austria
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Russia
  • United Kingdom

Study Locations

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Entities

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 NCT00643188 on ClinicalTrials.gov