NCT00272636

Brief Summary

The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2002

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
Last Updated

June 3, 2015

Status Verified

January 1, 2006

First QC Date

January 3, 2006

Last Update Submit

June 2, 2015

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablationamiodaronecardioversion

Outcome Measures

Primary Outcomes (1)

  • Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.

Secondary Outcomes (4)

  • incidence of complications

  • changes in left atrial diameter

  • changes in left ventricular ejection fraction

  • changes in symptom severity

Interventions

Radiofrequency catheter ablationPROCEDURE
Amiodarone and cardioversionDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic atrial fibrillation

You may not qualify if:

  • Left atrial diameter \>55 mm
  • Left ventricular ejection fraction \<0.30
  • Contraindication to amiodarone therapy or anticoagulation with warfarin
  • Presence of a mechanical prosthetic valve
  • History of a cerebrovascular accident
  • Presence of left atrial thrombus on TEE
  • Prior attempt at catheter or surgical ablation for atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

San Raffaele Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter AblationAmiodaroneElectric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsElectric Stimulation Therapy

Study Officials

  • Hakan Oral, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Fred Morady, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 6, 2006

Study Start

November 1, 2002

Study Completion

February 1, 2005

Last Updated

June 3, 2015

Record last verified: 2006-01

Locations

US(1)IT(1)