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Tailored Treatment of Permanent Atrial Fibrillation

NCT00514735 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2018-10-16

Study results available
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Summary

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

Conditions

Interventions

PROCEDURE

Medtronic Cardiac Ablation System

Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.

DRUG

Class I or III Antiarrhythmic Medications

Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

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
2007-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Netherlands

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 NCT00514735 on ClinicalTrials.gov