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High Intensity Focused Ultrasound (HIFU) Ablation System Study

NCT00392106 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2008-06-17

No results posted yet for this study

Summary

The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.

Conditions

Interventions

DRUG

propafenone

Anti-arrhythmic drug prescribed for treatment of atrial fibrillation

DRUG

flecainide

Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation

DRUG

dofetilide

Anti-arrhythmic drug prescribed for treatment of atrial fibrillation

DRUG

sotolol

Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation

DEVICE

Pulmonary vein ablation

Electrical isolation of pulmonary vein with high-intensity focused ultrasound

DRUG

Amiodarone

Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation

Sponsors & Collaborators

  • ProRhythm, Inc.

    lead INDUSTRY

Principal Investigators

  • Warren Jackman, MD · Oklahoma University Health Sciences Center

  • Hugh Calkins, MD · Johns Hopkins Medical Center

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
2006-04-30
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • United States
  • Czechia

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 NCT00392106 on ClinicalTrials.gov